The following data is part of a premarket notification filed by Rapid Diagnostic Laboratories, Inc. with the FDA for Cobe Cop Filter Cardiopulmonary Prebypass Filter.
| Device ID | K850139 |
| 510k Number | K850139 |
| Device Name: | COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER |
| Classification | Filter, Prebypass, Cardiopulmonary Bypass |
| Applicant | RAPID DIAGNOSTIC LABORATORIES, INC. }I85 OAK ST. Lakewood, CO 80215 |
| Contact | Holland Hickey |
| Correspondent | Holland Hickey RAPID DIAGNOSTIC LABORATORIES, INC. }I85 OAK ST. Lakewood, CO 80215 |
| Product Code | KRJ |
| CFR Regulation Number | 870.4280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-14 |
| Decision Date | 1985-04-10 |