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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 K041652
Device Name ACUPUNCTURE NEEDLES
Applicant
C.A.I. Industries Corp.
10166 Rush St.
South El Monte,  CA  91007
Applicant Contact LU RAO
Correspondent
C.A.I. Industries Corp.
10166 Rush St.
South El Monte,  CA  91007
Correspondent Contact LU RAO
Regulation Number880.5580
Classification Product Code
MQX  
Date Received06/17/2004
Decision Date 12/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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