The following data is part of a premarket notification filed by American Omni Medical, Inc. with the FDA for Silent Guard Cat. No. Sg-10.
| Device ID | K873488 |
| 510k Number | K873488 |
| Device Name: | SILENT GUARD CAT. NO. SG-10 |
| Classification | Adaptor, Stopcock, Manifold, Fitting, 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 | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-31 |
| Decision Date | 1987-10-07 |