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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K902178
Device Name YUEFA DISPOSABLE SYRINGE
Applicant
Blue & Red Corp.
1718 Laurel St.
Merrick,  NY  11566
Applicant Contact DEBBIE SUN
Correspondent
Blue & Red Corp.
1718 Laurel St.
Merrick,  NY  11566
Correspondent Contact DEBBIE SUN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/15/1990
Decision Date 12/21/1990
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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