The following data is part of a premarket notification filed by Grace Medical, Inc. with the FDA for Blue Ptfe (fluoroplastic) Ventilation Tubes.
| Device ID | K062385 |
| 510k Number | K062385 |
| Device Name: | BLUE PTFE (FLUOROPLASTIC) VENTILATION 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 | 2006-08-15 |
| Decision Date | 2006-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844505010313 | K062385 | 000 |
| 00844505004190 | K062385 | 000 |
| 00844505004183 | K062385 | 000 |
| 00844505004176 | K062385 | 000 |
| 00844505004169 | K062385 | 000 |
| 00844505004152 | K062385 | 000 |
| 00844505004138 | K062385 | 000 |
| 00844505004121 | K062385 | 000 |
| 00844505004091 | K062385 | 000 |
| 00844505004084 | K062385 | 000 |
| 00844505004077 | K062385 | 000 |
| 00844505004060 | K062385 | 000 |
| 00844505004053 | K062385 | 000 |
| 00844505004046 | K062385 | 000 |
| 00844505004039 | K062385 | 000 |
| 00844505004022 | K062385 | 000 |
| 10844505012611 | K062385 | 000 |
| 00844505012607 | K062385 | 000 |
| 00844505004206 | K062385 | 000 |
| 00844505004213 | K062385 | 000 |
| 00844505009256 | K062385 | 000 |
| 00844505009249 | K062385 | 000 |
| 00844505008501 | K062385 | 000 |
| 00844505008495 | K062385 | 000 |
| 00844505008488 | K062385 | 000 |
| 00844505008471 | K062385 | 000 |
| 00844505008464 | K062385 | 000 |
| 00844505008457 | K062385 | 000 |
| 00844505008440 | K062385 | 000 |
| 00844505008433 | K062385 | 000 |
| 00844505008426 | K062385 | 000 |
| 00844505008419 | K062385 | 000 |
| 00844505006415 | K062385 | 000 |
| 00844505004299 | K062385 | 000 |
| 00844505004244 | K062385 | 000 |
| 00844505004237 | K062385 | 000 |
| 00844505004220 | K062385 | 000 |
| 10844505012598 | K062385 | 000 |