The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Surgisis Staple Line Reinforcement.
| Device ID | K022044 |
| 510k Number | K022044 |
| Device Name: | SURGISIS STAPLE LINE REINFORCEMENT |
| Classification | Mesh, Surgical, Collagen, Staple Line Reinforcement |
| 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 | OXE |
| Subsequent Product Code | FTM |
| Subsequent Product Code | PAJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-24 |
| Decision Date | 2002-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002532035 | K022044 | 000 |