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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 K212932
Device Name Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray
Applicant
Nobel Biocare Services AG
BOX 5190, SE-402 26, Vastra Hamngatan 1
Goteborg,  SE SE-411 17
Applicant Contact Nick Lewis
Correspondent
Nobel Biocare Services AG
BOX 5190, SE-402 26, Vastra Hamngatan 1
Goteborg,  SE SE-411 17
Correspondent Contact Nick Lewis
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/15/2021
Decision Date 12/18/2021
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
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