The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Axiom Hydromer Wound Drains.
| Device ID | K832416 |
| 510k Number | K832416 |
| Device Name: | AXIOM HYDROMER WOUND DRAINS |
| Classification | Catheter, Ventricular, General & Plastic Surgery |
| Applicant | AXIOM MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GBS |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-21 |
| Decision Date | 1983-10-31 |