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) (8) Bed, Ac-Powered Adjustable Hospital (FNL) (1) Stretcher, Wheeled (FPO) (1)

Premarket Exempt

Yes

Clear

NA - 00842307100638 Catalog Number :

Device Description : WHEELCHAIR,30X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100645 Catalog Number :

Device Description : WHEELCHAIR,MR 26" X 20" DP,SS 650 lb capacity

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100652 Catalog Number :

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

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100669 Catalog Number :

Device Description : WHEELCHAIR,26"X18",BASIC 600 LB. CAPACITY

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100676 Catalog Number :

Device Description : WHEELCHAIR,28"X18",BASIC 600 LB. CAPACITY

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100683 Catalog Number :

Device Description : WHEELCHAIR,24"X18",DELUXE 350 LB CAPACITY

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100690 Catalog Number :

Device Description : WHEELCHAIR,28X20DP,REM ARM,Q/R850 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100706 Catalog Number :

Device Description : STRETCHER,TRANSPORT PLUS,28" HEIGHT ADJ ONLY CO153 3/6/07

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

NA - 00842307100713 Catalog Number :

Device Description : WHEELCHAIR,24X18DP,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 - 00842307100720 Catalog Number :

Device Description : BED,HOMECARE 39 X 84" 650 LB 3 FUNCTION BEECHWOOD

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

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