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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K880892
Device Name BLOOD COLLECTING NEEDLE AND HOLDERS
Applicant
ABCO DEALERS, INC.
6601 W. MILL RD.
P.O. BOX 23090
MILWAUKEE,  WI  53218 -1238
Applicant Contact MOLLY PETR
Correspondent
ABCO DEALERS, INC.
6601 W. MILL RD.
P.O. BOX 23090
MILWAUKEE,  WI  53218 -1238
Correspondent Contact MOLLY PETR
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/02/1988
Decision Date 04/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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