The following data is part of a premarket notification filed by American Omni Medical, Inc. with the FDA for Cardioplegia Overpressure Valve Cpop-350 & 700.
| Device ID | K884640 |
| 510k Number | K884640 |
| Device Name: | CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 |
| Classification | Accessory Equipment, 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 | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-07 |
| Decision Date | 1989-01-24 |