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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 K000816
Device Name SHARP BRAND ACUPUNCTURE NEEDLES
Applicant
Tcm Supply Corp.
15946 Kaplan Ave.
City Of Industry,  CA  91744
Applicant Contact WILLIAM HUNG LEE
Correspondent
Tcm Supply Corp.
15946 Kaplan Ave.
City Of Industry,  CA  91744
Correspondent Contact WILLIAM HUNG LEE
Regulation Number880.5580
Classification Product Code
MQX  
Date Received03/13/2000
Decision Date 05/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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