The following data is part of a premarket notification filed by Medtronic Xomed with the FDA for Hoffman H/a Coated Long-term Ventilation Tube With Liner.
| Device ID | K963727 |
| 510k Number | K963727 |
| Device Name: | HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER |
| Classification | Tube, Tympanostomy |
| Applicant | MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | David Timlin |
| Correspondent | David Timlin MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1997-02-11 |
| Summary: | summary |