The following data is part of a premarket notification filed by American Omni Medical, Inc. with the FDA for Prebypass Filter.
| Device ID | K871350 |
| 510k Number | K871350 |
| Device Name: | PREBYPASS FILTER |
| Classification | Filter, Prebypass, Cardiopulmonary Bypass |
| Applicant | AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa, CA 92626 |
| Contact | George G Siposs |
| Correspondent | George G Siposs AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa, CA 92626 |
| Product Code | KRJ |
| CFR Regulation Number | 870.4280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-06 |
| Decision Date | 1987-06-08 |