The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Pre-bypass Filter.
| Device ID | K812539 |
| 510k Number | K812539 |
| Device Name: | PRE-BYPASS FILTER |
| Classification | Filter, Prebypass, Cardiopulmonary Bypass |
| Applicant | GELMAN SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRJ |
| CFR Regulation Number | 870.4280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-03 |
| Decision Date | 1981-10-13 |