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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Orthodontic
510(k) Number K201919
Device Name Blue Sky Bio TAD
Applicant
Blue Sky Bio, LLC
800 Liberty Dr.
Libertyville,  IL  60048
Applicant Contact Sharon Nichols
Correspondent
Compliance4Devices
118 W Prive Cr.
118 W Prive Cr.,  FL  33445
Correspondent Contact Juan Tezak
Regulation Number872.3640
Classification Product Code
OAT  
Date Received07/10/2020
Decision Date 12/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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