The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Micromedics Ear, Nose And Throat Burs.
| Device ID | K895738 |
| 510k Number | K895738 |
| Device Name: | MICROMEDICS EAR, NOSE AND THROAT BURS |
| Classification | Bur, Ear, Nose And Throat |
| 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 | EQJ |
| CFR Regulation Number | 874.4140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1989-12-19 |