The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Silicone Soft-pak Epistaxis Catheter.
| Device ID | K832476 |
| 510k Number | K832476 |
| Device Name: | SILICONE SOFT-PAK EPISTAXIS CATHETER |
| Classification | Catheter, Nasopharyngeal |
| Applicant | AXIOM MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ENW |
| CFR Regulation Number | 874.4175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-26 |
| Decision Date | 1983-11-03 |