The following data is part of a premarket notification filed by Zimmer Patient Care Division with the FDA for Hemovac Autotransfusion System.
| Device ID | K920273 |
| 510k Number | K920273 |
| Device Name: | HEMOVAC AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | ZIMMER PATIENT CARE DIVISION 200 W. OHIO AVE. P.O. BOX 10 Dover, OH 44622 |
| Contact | Paula S Osorio |
| Correspondent | Paula S Osorio ZIMMER PATIENT CARE DIVISION 200 W. OHIO AVE. P.O. BOX 10 Dover, OH 44622 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-22 |
| Decision Date | 1993-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024021655 | K920273 | 000 |
| 00889024021648 | K920273 | 000 |
| 00889024021631 | K920273 | 000 |
| 00889024021624 | K920273 | 000 |
| 00889024021617 | K920273 | 000 |