The following data is part of a premarket notification filed by Ultracell Medical Technologies, Inc. with the FDA for Ultracell Instrument Wipe.
| Device ID | K920353 |
| 510k Number | K920353 |
| Device Name: | ULTRACELL INSTRUMENT WIPE |
| Classification | Monitor, Blood-flow, Ultrasonic |
| 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 | HEP |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-27 |
| Decision Date | 1992-09-15 |