The following data is part of a premarket notification filed by Solway, Inc. with the FDA for Rongeur (neurosurgical Instruments).
| Device ID | K875043 |
| 510k Number | K875043 |
| Device Name: | RONGEUR (NEUROSURGICAL INSTRUMENTS) |
| Classification | Rongeur, Manual |
| Applicant | SOLWAY, INC. POST OFFICE BOX 7647 Hollywood, FL 33081 |
| Contact | Martin Munzer |
| Correspondent | Martin Munzer SOLWAY, INC. POST OFFICE BOX 7647 Hollywood, FL 33081 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-02 |
| Decision Date | 1988-01-22 |