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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K190491
Device Name Blue Sky Bio Zygomatic Implant System
Applicant
Blue Sky Bio, LLC.
800 Liberty Drive
libertyville,  IL  60048
Applicant Contact michele kupcso
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact kevin a. thomas
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/28/2019
Decision Date 08/12/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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