FDA 510(k) Application Details - K955835

Device Classification Name	Cover, Shoe, Operating-Room   More FDA Info for this Device
510(K) Number	K955835
Device Name	Cover, Shoe, Operating-Room
Applicant	INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. OKEMOS, MI 48864 US Other 510(k) Applications for this Company
Contact	BRENDA J SPARKS Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/1995
Decision Date	11/19/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review