510(k) K901313
K901313 is an FDA 510(k) premarket notification submitted by Von Zeppelin GmbH for the device "INSTRUMENTS FOR NEUROLOGICAL SURGERY". The FDA issued a decision of Substantially Equivalent on July 23, 1990. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Von Zeppelin GmbH has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1990
- Date Received
- March 20, 1990
- 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