FDA 510(k) Application Details - K111341

Device Classification Name	More FDA Info for this Device
510(K) Number	K111341
Device Name	CLEANE / CLEANE POP
Applicant	MEDICON CO., LTD. 951 STARBUCK ST. UNIT J FULLERTON, CA 92833 US Other 510(k) Applications for this Company
Contact	Priscilla Chung Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2011
Decision Date	02/29/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review