The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Sis Plastic Surgery Matrix.
| Device ID | K034039 |
| 510k Number | K034039 |
| Device Name: | SIS PLASTIC SURGERY MATRIX |
| Classification | Mesh, Surgical |
| Applicant | COOK BIOTECH, INC. 3055 KENT AVE. West Lafayette, IN 47906 -1076 |
| Contact | Mark Bleyer |
| Correspondent | Mark Bleyer COOK BIOTECH, INC. 3055 KENT AVE. West Lafayette, IN 47906 -1076 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-29 |
| Decision Date | 2004-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002528666 | K034039 | 000 |
| 00827002528673 | K034039 | 000 |
| 00827002528659 | K034039 | 000 |
| 10827002528694 | K034039 | 000 |
| 10827002528687 | K034039 | 000 |