The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Modification To Surgisis Slr Staple Line Reinforcement.
| Device ID | K070405 |
| 510k Number | K070405 |
| Device Name: | MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-12 |
| Decision Date | 2007-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002542525 | K070405 | 000 |
| 00827002236622 | K070405 | 000 |
| 00827002248274 | K070405 | 000 |
| 00827002250062 | K070405 | 000 |
| 00827002250079 | K070405 | 000 |
| 00827002506565 | K070405 | 000 |
| 00827002508651 | K070405 | 000 |
| 00827002508668 | K070405 | 000 |
| 00827002508675 | K070405 | 000 |
| 00827002508682 | K070405 | 000 |
| 00827002508705 | K070405 | 000 |
| 00827002508712 | K070405 | 000 |
| 00827002517462 | K070405 | 000 |
| 00827002542518 | K070405 | 000 |
| 00827002232013 | K070405 | 000 |