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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K041779
Device Name NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
Applicant
Nipro Medical Corp.
1384 Copperfield Ct.
Lexington,  KY  40514
Applicant Contact KAELYN B HADLEY
Correspondent
Nipro Medical Corp.
1384 Copperfield Ct.
Lexington,  KY  40514
Correspondent Contact KAELYN B HADLEY
Regulation Number880.5440
Classification Product Code
FMG  
Date Received07/01/2004
Decision Date 09/21/2004
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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