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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K942902
FOIA Releasable 510(k) K942902
Device Name SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER
Applicant
Winfield Co., Inc.
7106 Crossroads Blvd.,
Suite 201
Brentwood,  TN  37027
Applicant Contact DAVID OLMSTEAD
Correspondent
Winfield Co., Inc.
7106 Crossroads Blvd.,
Suite 201
Brentwood,  TN  37027
Correspondent Contact DAVID OLMSTEAD
Regulation Number880.5570
Classification Product Code
MMK  
Date Received04/28/1994
Decision Date 12/15/1994
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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