The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Glassman Silicone Catheter.
| Device ID | K934895 |
| 510k Number | K934895 |
| Device Name: | GLASSMAN SILICONE CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | AXIOM MEDICAL, INC. 555 WEST VICTORIA ST. Rancho Dominguez, CA 90220 |
| Contact | Ridwan Hardy |
| Correspondent | Ridwan Hardy AXIOM MEDICAL, INC. 555 WEST VICTORIA ST. Rancho Dominguez, CA 90220 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-05 |
| Decision Date | 1994-10-13 |