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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 K981184
Device Name SHARPTRACK REUSABLE SHARPS CONTAINER
Applicant
Bfi- Medical Waste Systems
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Applicant Contact A W SIEGNER
Correspondent
Bfi- Medical Waste Systems
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact A W SIEGNER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/01/1998
Decision Date 06/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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