FDA 510(k) Application Details - K120898

Device Classification Name	More FDA Info for this Device
510(K) Number	K120898
Device Name	KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
Applicant	RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. VERNON HILLS, IL 60061 US Other 510(k) Applications for this Company
Contact	RON HASELHORST Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2012
Decision Date	08/03/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review