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 |