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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K850111
Device Name AIRES TUOHY NEEDLES 17GA. X 4 1/2
Applicant
ARIES MEDICAL, INC.
TWO GILL ST.
WOBURN,  MA  01801
Applicant Contact MICHAEL RISHTON
Correspondent
ARIES MEDICAL, INC.
TWO GILL ST.
WOBURN,  MA  01801
Correspondent Contact MICHAEL RISHTON
Regulation Number868.5150
Classification Product Code
BSP  
Date Received01/14/1985
Decision Date 01/24/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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