FDA 510(k) Application Details - K973594

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K973594
Device Name	Bone Grafting Material, Synthetic
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	872.3930   More FDA Info for this Regulation Number
Classification Product Code	LYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/1997
Decision Date	12/17/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review