The following data is part of a premarket notification filed by American Omni Medical, Inc. with the FDA for Exu-bag Csu-1200(dispos)canister 602-2(non-dispos.
| Device ID | K852178 |
| 510k Number | K852178 |
| Device Name: | EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS |
| Classification | Apparatus, Autotransfusion |
| 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 | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-20 |
| Decision Date | 1985-12-27 |