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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 K162600
Device Name Jewel Precision Reusable Rigid Sterilization Container System
Applicant
JEWEL PRECISION SHEET METAL & MACHINE, INC.
200 COMMERCE ROAD
CEDAR GROVE,  NJ  07009
Applicant Contact GARY SCHNEBERGER
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/19/2016
Decision Date 12/09/2016
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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