FDA 510(k) Application Details - K970835

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K970835
Device Name	Mask, Surgical
Applicant	TUCKER & ASSOCIATES 19001 SOUTH RICHFIELD, SUITE 185 GREEN VALLEY, AZ 85614 US Other 510(k) Applications for this Company
Contact	JANNA P TUCKER Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/1997
Decision Date	09/03/1997
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