The following data is part of a premarket notification filed by Grace Medical, Inc. with the FDA for Grace Medical Pc Coated Tympanostomy Tubes.
| Device ID | K062672 |
| 510k Number | K062672 |
| Device Name: | GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES |
| Classification | Tube, Tympanostomy |
| Applicant | Grace Medical, Inc. 8500 WOLF LAKE DR., STE. 110 Memphis, TN 38133 |
| Contact | Jeff Cobb |
| Correspondent | Jeff Cobb Grace Medical, Inc. 8500 WOLF LAKE DR., STE. 110 Memphis, TN 38133 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-08 |
| Decision Date | 2006-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844505011570 | K062672 | 000 |
| 00844505003117 | K062672 | 000 |
| 00844505003094 | K062672 | 000 |
| 00844505003063 | K062672 | 000 |
| 00844505003032 | K062672 | 000 |
| 00844505003001 | K062672 | 000 |
| 00844505002912 | K062672 | 000 |
| 00844505002882 | K062672 | 000 |
| 00844505002851 | K062672 | 000 |
| 00844505002813 | K062672 | 000 |
| 00844505002790 | K062672 | 000 |
| 00844505002776 | K062672 | 000 |
| 00844505002721 | K062672 | 000 |
| 00844505003124 | K062672 | 000 |
| 00844505003148 | K062672 | 000 |
| 00844505003186 | K062672 | 000 |
| 00844505010245 | K062672 | 000 |
| 00844505009034 | K062672 | 000 |
| 00844505007870 | K062672 | 000 |
| 00844505007832 | K062672 | 000 |
| 00844505007672 | K062672 | 000 |
| 00844505006675 | K062672 | 000 |
| 00844505006552 | K062672 | 000 |
| 00844505003520 | K062672 | 000 |
| 00844505003513 | K062672 | 000 |
| 00844505003391 | K062672 | 000 |
| 00844505003384 | K062672 | 000 |
| 00844505003209 | K062672 | 000 |
| 00844505002677 | K062672 | 000 |