The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Disposable Fluid Collection Bag.
| Device ID | K904133 |
| 510k Number | K904133 |
| Device Name: | DISPOSABLE FLUID COLLECTION BAG |
| Classification | Catheter, Irrigation |
| Applicant | AXIOM MEDICAL, INC. 7625 ROSECRANS AVE. SUITE 29/ P.O. BOX 1306 Paramount, CA 90723 |
| Contact | Mahendra Sanghvi |
| Correspondent | Mahendra Sanghvi AXIOM MEDICAL, INC. 7625 ROSECRANS AVE. SUITE 29/ P.O. BOX 1306 Paramount, CA 90723 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-06 |
| Decision Date | 1990-10-11 |