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510(k) K961802

PRECLUDE SYNBLOC MEMBRANE by W. L. Gore & Associates, Inc. — Product Code GXO

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

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Other clearances for product code GXO

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