The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Micromedics Sterile, Disposable Ent Exam Kit.
| Device ID | K860940 |
| 510k Number | K860940 |
| Device Name: | MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT |
| Classification | Unit, Examining/treatment, Ent |
| Applicant | MICROMEDICS, INC. 268 E. LAFAYETTE FRONTAGE ROAD St. Paul, MN 55107 |
| Contact | Curtis H Miller |
| Correspondent | Curtis H Miller MICROMEDICS, INC. 268 E. LAFAYETTE FRONTAGE ROAD St. Paul, MN 55107 |
| Product Code | ETF |
| CFR Regulation Number | 874.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-12 |
| Decision Date | 1986-05-02 |