The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Atraum Wound Dressing.
| Device ID | K852614 |
| 510k Number | K852614 |
| Device Name: | ATRAUM WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | AXIOM MEDICAL, INC. 7625 ROSECRANS AVE. SUITE 29/ P.O. BOX 1306 Paramount, CA 90723 |
| Contact | Roger Wood |
| Correspondent | Roger Wood AXIOM MEDICAL, INC. 7625 ROSECRANS AVE. SUITE 29/ P.O. BOX 1306 Paramount, CA 90723 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-20 |
| Decision Date | 1985-08-30 |