The following data is part of a premarket notification filed by Cousin Biotech S.a.s. with the FDA for Cabs'air.
Device ID | K072962 |
510k Number | K072962 |
Device Name: | CABS'AIR |
Classification | Mesh, Surgical, Polymeric |
Applicant | COUSIN BIOTECH S.A.S. 8 RUE DE L'ABBE BONPAIN Wervicq-sud, FR 59117 |
Contact | Stephen Ploquin |
Correspondent | Stephen Ploquin COUSIN BIOTECH S.A.S. 8 RUE DE L'ABBE BONPAIN Wervicq-sud, FR 59117 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-19 |
Decision Date | 2008-06-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03760185570381 | K072962 | 000 |
03760185570367 | K072962 | 000 |