The following data is part of a premarket notification filed by Sulzer Carbomedics, Inc. with the FDA for Sulzer Carbomedics Cardiofix Pericardium.
| Device ID | K993288 |
| 510k Number | K993288 |
| Device Name: | SULZER CARBOMEDICS CARDIOFIX PERICARDIUM |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Contact | Edward E Newton |
| Correspondent | Edward E Newton SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-01 |
| Decision Date | 1999-12-29 |
| Summary: | summary |