The following data is part of a premarket notification filed by Synovis Surgical Innovations with the FDA for Peri-strips Staple Line Reinforcement - Sleeve And Strip Configurations - And Peri-strips Dry Staple Line Reinforcement.
| Device ID | K040415 |
| 510k Number | K040415 |
| Device Name: | PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. WEST St. Paul, MN 55114 -1024 |
| Contact | Angela Mallery |
| Correspondent | Angela Mallery SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. WEST St. Paul, MN 55114 -1024 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-18 |
| Decision Date | 2004-04-14 |
| Summary: | summary |