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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 K111085
Device Name SHARPS TANK REUSABLE SHARPS CONTAINER
Applicant
Rehrig Pacific Company
614 Hunters Lane
Brentwood,  TN  37027
Applicant Contact DAVID OLMSTEAD
Correspondent
Rehrig Pacific Company
614 Hunters Lane
Brentwood,  TN  37027
Correspondent Contact DAVID OLMSTEAD
Regulation Number880.5570
Classification Product Code
MMK  
Date Received04/19/2011
Decision Date 04/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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