FDA 510(k) Application Details - K961802

Device Classification Name	Strip, Craniosynostosis, Preformed   More FDA Info for this Device
510(K) Number	K961802
Device Name	Strip, Craniosynostosis, Preformed
Applicant	W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD ELKTON, MD 21922-1408 US Other 510(k) Applications for this Company
Contact	JOHN W NICHOLSON Other 510(k) Applications for this Contact
Regulation Number	882.5900   More FDA Info for this Regulation Number
Classification Product Code	GXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/1996
Decision Date	07/31/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review