The following data is part of a premarket notification filed by Medical Instruments Corporation, Ag with the FDA for Modification To: Pronto Dry.
| Device ID | K002451 |
| 510k Number | K002451 |
| Device Name: | MODIFICATION TO: PRONTO DRY |
| Classification | Helicobacter Pylori |
| Applicant | MEDICAL INSTRUMENTS CORPORATION, AG POB 706 CH-4502 Solothurn, CH Ch-4502 |
| Contact | John C Matherly |
| Correspondent | John C Matherly MEDICAL INSTRUMENTS CORPORATION, AG POB 706 CH-4502 Solothurn, CH 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 | 2000-08-09 |
| Decision Date | 2000-09-29 |