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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 K983671
Device Name NATURAL BRAND ACUPUNCTURE NEEDLES
Applicant
Tcm Supply Corp.
12490 Central Ave., Suite 221
Chino,  CA  91710
Applicant Contact WILLIAM HUNG LEE
Correspondent
Tcm Supply Corp.
12490 Central Ave., Suite 221
Chino,  CA  91710
Correspondent Contact WILLIAM HUNG LEE
Regulation Number880.5580
Classification Product Code
MQX  
Date Received10/19/1998
Decision Date 03/04/1999
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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