The following data is part of a premarket notification filed by Ear Tech, Inc. with the FDA for Ear Curette.
| Device ID | K932609 |
| 510k Number | K932609 |
| Device Name: | EAR CURETTE |
| Classification | Curette, Ear |
| Applicant | EAR TECH, INC. 207 E. MYRTLE AVE. Johnson City, TN 37601 |
| Contact | Richard J Gilbert |
| Correspondent | Richard J Gilbert EAR TECH, INC. 207 E. MYRTLE AVE. Johnson City, TN 37601 |
| Product Code | JYG |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-28 |
| Decision Date | 1993-07-21 |