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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 K073577
Device Name SHARPS TRANSPORT TUBE, MODEL 50035
Applicant
Sharps Compliance, Inc.
614 Hunters Ln.
Brentwood,  TN  37027
Applicant Contact DAVID OLMSTEAD
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number880.5570
Classification Product Code
MMK  
Date Received12/20/2007
Decision Date 06/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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