The following data is part of a premarket notification filed by American Omni Medical, Inc. with the FDA for Flow Control Valve, Cat. No. Acv-38.
| Device ID | K922356 |
| 510k Number | K922356 |
| Device Name: | FLOW CONTROL VALVE, CAT. NO. ACV-38 |
| Classification | Cpb Check Valve, Retrograde Flow, In-line |
| Applicant | AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa, CA 92626 |
| Contact | Kathryn Bucklein |
| Correspondent | Kathryn Bucklein AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa, CA 92626 |
| Product Code | MJJ |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-19 |
| Decision Date | 1993-02-12 |