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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 K960769
Device Name ACUPUNCTURE NEEDLE PACK
Applicant
Acu-Med, Inc.
2701 W. Alameda Ave., #301
Burbank,  CA  91505
Applicant Contact JEUNG H CHOI, M.D.
Correspondent
Acu-Med, Inc.
2701 W. Alameda Ave., #301
Burbank,  CA  91505
Correspondent Contact JEUNG H CHOI, M.D.
Regulation Number880.5580
Classification Product Code
MQX  
Date Received02/26/1996
Decision Date 07/10/1996
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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