The following data is part of a premarket notification filed by Cousin Biotech S.a.s. with the FDA for Biomesh Ca.b.s. 'air Composite, Models: Cabst1r05t, Cabsairc7, Cabsairc09.
Device ID | K093196 |
510k Number | K093196 |
Device Name: | BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 |
Classification | Mesh, Surgical, Polymeric |
Applicant | COUSIN BIOTECH S.A.S. 8 RUE DE L'ABBE BONPAIN Wervicq-sud, FR 59117 |
Contact | Franck Pelletier |
Correspondent | Franck Pelletier 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 | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-10-09 |
Decision Date | 2010-06-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03760185570374 | K093196 | 000 |
03760185570343 | K093196 | 000 |
03760185570336 | K093196 | 000 |