The following data is part of a premarket notification filed by Genetic Laboratories, Inc. with the FDA for Peri-guard Pericardial Patch.
| Device ID | K842066 |
| 510k Number | K842066 |
| Device Name: | PERI-GUARD PERICARDIAL PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | GENETIC LABORATORIES, INC. 1385 DENTENNIAL DRIVE St. Paul , MN 55113 - |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-23 |
| Decision Date | 1985-12-30 |