The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Godde T-tube Blue Silicone Tympanostomy Tube.
| Device ID | K853641 |
| 510k Number | K853641 |
| Device Name: | GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE |
| Classification | Tube, Tympanostomy |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Thomas A Smith |
| Correspondent | Thomas A Smith XOMED, INC. 6743 SOUTHPOINT DR. 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 | 1985-09-03 |
| Decision Date | 1986-01-06 |