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 |