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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K954823
Device Name VENIPUNCTURE KIT
Applicant
Winfield Industries
9750 Distribution Ave.
San Diego,  CA  92121
Applicant Contact DAVID OLMSTEAD
Correspondent
Winfield Industries
9750 Distribution Ave.
San Diego,  CA  92121
Correspondent Contact DAVID OLMSTEAD
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/20/1995
Decision Date 01/30/1996
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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