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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, root-form
510(k) Number K153064
Device Name Blue Sky Bio Zygomatic Implant System
Applicant
BLUE SKY BIO, LLC
888 E BELVIDERE RD.
SUITE 212
grayslake,  IL  60030
Applicant Contact michele vovolka
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact kevin a thomas
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received10/22/2015
Decision Date 04/29/2016
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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