The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Silverstein Microwick.
| Device ID | K991670 |
| 510k Number | K991670 |
| Device Name: | SILVERSTEIN MICROWICK |
| Classification | Tube, Tympanostomy |
| Applicant | MICROMEDICS, INC. 1285 CORPORATE CENTER DR., #150 Eagan, MN 55121 |
| Contact | Charles Grote |
| Correspondent | Charles Grote MICROMEDICS, INC. 1285 CORPORATE CENTER DR., #150 Eagan, MN 55121 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-17 |
| Decision Date | 1999-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385640014618 | K991670 | 000 |
| 00385640014601 | K991670 | 000 |