510(k) K962372
K962372 is an FDA 510(k) premarket notification submitted by Influence, Inc. for the device "UROTAC BONE ANCHOR INSERTER". The FDA issued a decision of Substantially Equivalent on August 19, 1996. The device falls under product code HXJ (Staple Driver), a Class I device regulated under 21 CFR 888.4540. Influence, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 1996
- Date Received
- June 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple Driver
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type