The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Surgisis Peyronie's Repair Graft, Model Spr-100.
| Device ID | K062320 |
| 510k Number | K062320 |
| Device Name: | SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 |
| Classification | Mesh, Surgical |
| Applicant | COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
| Contact | Mary A Faderan |
| Correspondent | Mary A Faderan COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-09 |
| Decision Date | 2006-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002476551 | K062320 | 000 |
| 10827002476544 | K062320 | 000 |
| 00827002476554 | K062320 | 000 |
| 00827002476547 | K062320 | 000 |