The following data is part of a premarket notification filed by Synovis Life Technologies. Inc. with the FDA for Peri-guard Repair Patch & Supple Peri-guard Repair Patch.
| Device ID | K142447 |
| 510k Number | K142447 |
| Device Name: | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | Synovis Life Technologies. Inc. 2575 University Ave. W. St. Paul, MN 55129 |
| Contact | Jodi Jorgenson |
| Correspondent | Jodi Jorgenson Synovis Life Technologies. Inc. 2575 University Ave. W. St. Paul, MN 55129 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-02 |
| Decision Date | 2015-01-07 |
| Summary: | summary |