510(k) K875043
K875043 is an FDA 510(k) premarket notification submitted by Solway, Inc. for the device "RONGEUR (NEUROSURGICAL INSTRUMENTS)". The FDA issued a decision of Substantially Equivalent on January 22, 1988. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Solway, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 1988
- Date Received
- December 2, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Manual
- Device Class
- Class II
- Regulation Number
- 882.4840
- Review Panel
- NE
- Submission Type