The following data is part of a premarket notification filed by Ultracell Medical Technologies, Inc. with the FDA for Nasal-sinus Packing.
| Device ID | K924542 |
| 510k Number | K924542 |
| Device Name: | NASAL-SINUS PACKING |
| Classification | Balloon, Epistaxis |
| Applicant | ULTRACELL MEDICAL TECHNOLOGIES, INC. P.O. BOX 326 North Stonington, CT 06359 |
| Contact | George P Korteweg |
| Correspondent | George P Korteweg ULTRACELL MEDICAL TECHNOLOGIES, INC. P.O. BOX 326 North Stonington, CT 06359 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-08 |
| Decision Date | 1993-02-12 |