The following data is part of a premarket notification filed by Medical Instruments Corporation Mic Ag with the FDA for Pronto Dry.
Device ID | K991248 |
510k Number | K991248 |
Device Name: | PRONTO DRY |
Classification | Helicobacter Pylori |
Applicant | MEDICAL INSTRUMENTS CORPORATION MIC AG FRIEDHOFPLATZ 16 Solothurn, CH 4502 |
Contact | John C Matherly |
Correspondent | John C Matherly MEDICAL INSTRUMENTS CORPORATION MIC AG FRIEDHOFPLATZ 16 Solothurn, CH 4502 |
Product Code | LYR |
CFR Regulation Number | 866.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-12 |
Decision Date | 1999-06-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRONTO DRY 78973310 3265162 Live/Registered |
ARJ Medical, Inc. 2006-09-13 |