The following data is part of a premarket notification filed by Ultracell Medical Technologies, Inc. with the FDA for Anterior/posterior Epistaxis Catheter.
| Device ID | K945556 |
| 510k Number | K945556 |
| Device Name: | ANTERIOR/POSTERIOR EPISTAXIS CATHETER |
| Classification | Balloon, Epistaxis |
| Applicant | ULTRACELL MEDICAL TECHNOLOGIES, INC. POST OFFICE BOX 609 Old Mystic, CT 06372 |
| Contact | George P Korteweg |
| Correspondent | George P Korteweg ULTRACELL MEDICAL TECHNOLOGIES, INC. POST OFFICE BOX 609 Old Mystic, CT 06372 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-01-18 |