FDA 510(k) Application Details - K953879

Device Classification Name	Cap, Surgical   More FDA Info for this Device
510(K) Number	K953879
Device Name	Cap, Surgical
Applicant	AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 ENKA, NC 28728 US Other 510(k) Applications for this Company
Contact	GREGORY B SCOTT Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/1995
Decision Date	01/05/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review