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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 K883009
Device Name NON-CORING NEEDLES
Applicant
QUINTON, INC.
2121 TERRY AVE.
SEATLE,  WA  98121
Applicant Contact RON R DUCK
Correspondent
QUINTON, INC.
2121 TERRY AVE.
SEATLE,  WA  98121
Correspondent Contact RON R DUCK
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/19/1988
Decision Date 10/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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