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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name over the counter thermal treatment for acne.
510(k) Number K111341
Device Name CLEANE / CLEANE POP
Applicant
MEDICON CO., LTD.
951 STARBUCK ST.
UNIT J
FULLERTON,  CA  92833
Applicant Contact Priscilla Chung
Correspondent
MEDICON CO., LTD.
951 STARBUCK ST.
UNIT J
FULLERTON,  CA  92833
Correspondent Contact Priscilla Chung
Regulation Number890.5740
Classification Product Code
OZC  
Date Received05/12/2011
Decision Date 02/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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