FDA 510(k) Application Details - K972634

Device Classification Name	Gauze/Sponge, Internal, X-Ray Detectable   More FDA Info for this Device
510(K) Number	K972634
Device Name	Gauze/Sponge, Internal, X-Ray Detectable
Applicant	ULTRACELL MEDICAL TECHNOLOGIES, INC. 183 PROVIDENCE, NEW LONDON TNPK NORTH STONINGTON, CT 06359 US Other 510(k) Applications for this Company
Contact	GEORGE P KORTEWEG Other 510(k) Applications for this Contact
Regulation Number	878.4450   More FDA Info for this Regulation Number
Classification Product Code	GDY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/1997
Decision Date	12/17/1997
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