GENDRON, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Chair, With Casters (INM) (10)

Premarket Exempt

Yes

Clear

NA - 00842307100430 Catalog Number :

Device Description : WHEELCHAIR,24"X18",BASIC 350 LB CAPACITY REL03-01 01/17/03 WHEELCHAIR,24"X18",BASIC 350 LB CAPACITY REL03-01 01/17/03 EC03-08 3/25/03

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100447 Catalog Number :

Device Description : WHEELCHAIR,26"X18",BASIC 600 LB. CAPACITY REL03-01A 03/03/03 WHEELCHAIR,26"X18",BASIC 600 LB. CAPACITY REL03-01A 03/03/03 EC03-08 3/26/03

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100454 Catalog Number :

Device Description : WHEELCHAIR,24"X18",DELUXE 450 LB CAPACITY

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100461 Catalog Number :

Device Description : WHEELCHAIR,24X20DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100478 Catalog Number :

Device Description : WHEELCHAIR,24X20DP,REM ARM,Q/R

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100485 Catalog Number :

Device Description : WHEELCHAIR,24X20DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100492 Catalog Number :

Device Description : WHEELCHAIR,24X22DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100508 Catalog Number :

Device Description : WHEELCHAIR,32X18DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100515 Catalog Number :

Device Description : WHEELCHAIR,32X20DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100522 Catalog Number :

Device Description : WHEELCHAIR,32X20DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

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