FDA 510(k) Application Details - K133121

Device Classification Name	More FDA Info for this Device
510(K) Number	K133121
Device Name	CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT
Applicant	SAM MEDICAL PRODUCTS 27350 SW 95TH AVE STE 3038 Wilsonville, OR 97070 US Other 510(k) Applications for this Company
Contact	JACK MCCUTCHEON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2013
Decision Date	05/22/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review