FDA 510(k) Application Details - K955646

Device Classification Name	Barrier, Synthetic, Intraoral   More FDA Info for this Device
510(K) Number	K955646
Device Name	Barrier, Synthetic, Intraoral
Applicant	ETHICON, INC. P.O BOX 151, ROUTE 22 WEST SOMERVILLE, NJ 08876 US Other 510(k) Applications for this Company
Contact	JOHN D PAULSON Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/1995
Decision Date	05/20/1996
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