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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 K030190
Device Name CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES
Applicant
Suzhou Sen Sen Medical Supplies , Ltd.
4500 Sheppard Ave. E.
Unit #1, Scarborough
Ontario,  CA
Applicant Contact KEVIN LIU
Correspondent
Suzhou Sen Sen Medical Supplies , Ltd.
4500 Sheppard Ave. E.
Unit #1, Scarborough
Ontario,  CA
Correspondent Contact KEVIN LIU
Regulation Number880.5580
Classification Product Code
MQX  
Date Received01/21/2003
Decision Date 02/21/2003
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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