The following data is part of a premarket notification filed by Sur-med Instruments, Inc. with the FDA for T-tube Inserter.
| Device ID | K870978 |
| 510k Number | K870978 |
| Device Name: | T-TUBE INSERTER |
| Classification | Inserter, Myringotomy Tube |
| Applicant | SUR-MED INSTRUMENTS, INC. 9422-24 GRAVOIS RD. St. Louis, MO 63123 |
| Contact | Christa K Nagel |
| Correspondent | Christa K Nagel SUR-MED INSTRUMENTS, INC. 9422-24 GRAVOIS RD. St. Louis, MO 63123 |
| Product Code | JYM |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-10 |
| Decision Date | 1987-03-19 |