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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 K974527
Device Name KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE
Applicant
American Institute of Koryo Hand Therapy
1800 Century Park East.
Suite 600
Los Angeles,  CA  90067
Applicant Contact JIN HAE LEW
Correspondent
American Institute of Koryo Hand Therapy
1800 Century Park East.
Suite 600
Los Angeles,  CA  90067
Correspondent Contact JIN HAE LEW
Regulation Number880.5580
Classification Product Code
MQX  
Date Received12/02/1997
Decision Date 01/13/1998
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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