SOFREGEN MEDICAL INC.

Address:175 Crossing Boulevard,Framingham,MA,01702,US

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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

System, Vocal Cord Medialization (MIX) (3)

Premarket Exempt

Clear

SilkVoice - B611SV20011 Catalog Number : SV2001

Device Description : SilkVoice catheter 70cm

Device Class : 2

Duns Number: 079710838

Premarket Exempt : No

Product Code : MIX

Prescription Use : Yes

Device Count : 1

SilkVoice - B611SV3001 Catalog Number : SV3001

Device Description : SilkVoice injectable implant and accessory kit.

Device Class : 2

Duns Number: 079710838

Premarket Exempt : No

Product Code : MIX

Prescription Use : Yes

Device Count : 1

SilkVoice - B611SV30012 Catalog Number : SV3001

Device Description : SilkVoice injectable implant and accessory kit.

Device Class : 2

Duns Number: 079710838

Premarket Exempt : No

Product Code : MIX

Prescription Use : Yes

Device Count : 1

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