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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 K163600
Device Name Kit Boxes and Kit Plates
Applicant
Nobel Biocare AB
Vastra Hamngatan 1
Goteborg,  SE SE-411 17
Applicant Contact Charlemagne Chua
Correspondent
Nobel Biocare USA, LLC
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Correspondent Contact Chalemagne Chua
Regulation Number880.6850
Classification Product Code
KCT  
Date Received12/21/2016
Decision Date 01/22/2018
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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