510(k) K961802
K961802 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "PRECLUDE SYNBLOC MEMBRANE". The FDA issued a decision of Substantially Equivalent on July 31, 1996. The device falls under product code GXO (Strip, Craniosynostosis, Preformed), a Class II device regulated under 21 CFR 882.5900. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1996
- Date Received
- May 9, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strip, Craniosynostosis, Preformed
- Device Class
- Class II
- Regulation Number
- 882.5900
- Review Panel
- NE
- Submission Type