FDA 510(k) Application Details - K963675

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K963675
Device Name	Drape, Surgical
Applicant	MICRO-MEDICAL DEVICES, INC. 317 PARAGON WAY CASTLE ROCK, CO 80104 US Other 510(k) Applications for this Company
Contact	EDWIN L ADAIR, M.D. Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	KKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/1996
Decision Date	01/27/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review