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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Acupuncture, Single Use
510(k) Number K142760
Device Name Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
Applicant
K.S. Choi Corporation
179 W 39th St.
Los Angeles,  CA  90037
Applicant Contact Kak Soo Choi
Correspondent
K.S. Choi Corporation
179 W 39th St.
Los Angeles,  CA  90037
Correspondent Contact Kak Soo Choi
Regulation Number880.5580
Classification Product Code
MQX  
Date Received09/25/2014
Decision Date 08/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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