The following data is part of a premarket notification filed by Ultracell Medical Technologies, Inc. with the FDA for Ultracell Ear Wick.
| Device ID | K920357 |
| 510k Number | K920357 |
| Device Name: | ULTRACELL EAR WICK |
| Classification | Ear Wick |
| 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 | KCN |
| CFR Regulation Number | 874.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-27 |
| Decision Date | 1993-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30886158014783 | K920357 | 000 |
| 30886158014684 | K920357 | 000 |
| 30886158014332 | K920357 | 000 |