The following data is part of a premarket notification filed by Xomed-treace, Inc. with the FDA for Tympanostomy (ventilation) Tube.
| Device ID | K941407 |
| 510k Number | K941407 |
| Device Name: | TYMPANOSTOMY (VENTILATION) TUBE |
| Classification | Tube, Tympanostomy |
| Applicant | XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
| Contact | Arthur A Gertzman |
| Correspondent | Arthur A Gertzman XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-23 |
| Decision Date | 1995-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20681490063993 | K941407 | 000 |
| 20681490029562 | K941407 | 000 |
| 20681490029555 | K941407 | 000 |
| 20681490029548 | K941407 | 000 |
| 20681490029531 | K941407 | 000 |
| 20681490029524 | K941407 | 000 |
| 20681490029517 | K941407 | 000 |
| 20681490029500 | K941407 | 000 |
| 20681490029494 | K941407 | 000 |
| 20681490029579 | K941407 | 000 |
| 20681490029586 | K941407 | 000 |
| 20681490031398 | K941407 | 000 |
| 20681490031381 | K941407 | 000 |
| 20681490031374 | K941407 | 000 |
| 20681490031367 | K941407 | 000 |
| 20681490031350 | K941407 | 000 |
| 20681490029616 | K941407 | 000 |
| 20681490029609 | K941407 | 000 |
| 20681490029593 | K941407 | 000 |
| 20681490029487 | K941407 | 000 |