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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 K962787
Device Name TAKI DISPOSABLE ACUPUNCTURE NEEDLE
Applicant
ACUPUNCTURE SUPPLIES IMPORT CO.
11306 EAST 183RD ST., #202
CERRITOS,  CA  90703
Applicant Contact LYNN H HSU
Correspondent
ACUPUNCTURE SUPPLIES IMPORT CO.
11306 EAST 183RD ST., #202
CERRITOS,  CA  90703
Correspondent Contact LYNN H HSU
Regulation Number880.5580
Classification Product Code
MQX  
Date Received07/17/1996
Decision Date 07/26/1996
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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