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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 K141759
Device Name OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS
Applicant
Oak Ridge Products, LLC
4612 Century Ct.
Mchenry,  IL  60050
Applicant Contact CONOR J O'MALLEY
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5570
Classification Product Code
MMK  
Date Received07/01/2014
Decision Date 10/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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