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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 K152745
Device Name ReNew Sterilization Trays(Catalog #3708 and #3709)
Applicant
Microline Surgical, Inc.
50 Dunham Rd., Suite 1500
Beverly,  MA  01915
Applicant Contact ANU GAUR
Correspondent
Microline Surgical, Inc.
50 Dunham Rd., Suite 1500
Beverly,  MA  01915
Correspondent Contact ANU GAUR
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/23/2015
Decision Date 05/12/2016
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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