The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Pre-bypass Filter #ec-pbf Series.
| Device ID | K832594 |
| 510k Number | K832594 |
| Device Name: | PRE-BYPASS FILTER #EC-PBF SERIES |
| Classification | Filter, Prebypass, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KRJ |
| CFR Regulation Number | 870.4280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-02 |
| Decision Date | 1983-09-20 |