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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 K942054
FOIA Releasable 510(k) K942054
Device Name SHARPS-TAINER
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 Number880.5570
Classification Product Code
FMI  
Date Received04/28/1994
Decision Date 08/23/1994
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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