The following data is part of a premarket notification filed by Sur-med Instruments, Inc. with the FDA for Special Rongeur.
| Device ID | K903401 |
| 510k Number | K903401 |
| Device Name: | SPECIAL RONGEUR |
| Classification | Rongeur, Manual |
| 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 | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1990-08-10 |