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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K152014
Device Name MTS300 Multiple Tray Sterilization System
Applicant
Pmbs, LLC
40 Milltown Rd.
Stockton,  NJ  08559
Applicant Contact MICHELE E. MAUZERALL
Correspondent
Hillring & Associates, Inc.
3012 St. Charles Dr.
Tampa,  FL  33618
Correspondent Contact ANNETTE M. HILLRING
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/21/2015
Decision Date 10/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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