The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Surgisis Rvp Recto-vaginal Fistula Plug.
| Device ID | K062729 |
| 510k Number | K062729 |
| Device Name: | SURGISIS RVP RECTO-VAGINAL FISTULA PLUG |
| Classification | Mesh, Surgical |
| Applicant | COOK BIOTECH, INC. 1400 CUMBERLAND AVE. West Lafayette, IN 47906 |
| Contact | Daniel J Dillon |
| Correspondent | Daniel J Dillon COOK BIOTECH, INC. 1400 CUMBERLAND AVE. West Lafayette, IN 47906 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-13 |
| Decision Date | 2006-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002546141 | K062729 | 000 |
| 00827002546134 | K062729 | 000 |
| 00827002546127 | K062729 | 000 |
| 10827002542027 | K062729 | 000 |
| 10827002542010 | K062729 | 000 |
| 10827002542003 | K062729 | 000 |