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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 K980472
Device Name KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE
Applicant
American Institute of Koryo Hand Therapy
17870 Castleton St., Suite 265
Industry,  CA  91748
Applicant Contact GEORGE SU
Correspondent
American Institute of Koryo Hand Therapy
17870 Castleton St., Suite 265
Industry,  CA  91748
Correspondent Contact GEORGE SU
Regulation Number880.5580
Classification Product Code
MQX  
Date Received02/06/1998
Decision Date 04/09/1998
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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