510(k) K974392
K974392 is an FDA 510(k) premarket notification submitted by Biovision GmbH for the device "LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM". The FDA issued a decision of Substantially Equivalent on January 30, 1998. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Biovision GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1998
- Date Received
- November 21, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Intraosseous
- Device Class
- Class II
- Regulation Number
- 872.4880
- Review Panel
- DE
- Submission Type