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FDA 510(k) Application Details - K163251
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K163251
Device Name
Powder, Porcelain
Applicant
BLUE SKY BIO
888 E BELVEDERE RD
SUITE 212
GRAYSLAKE, IL 60030 US
Other 510(k) Applications for this Company
Contact
ALBERT ZICKMANN
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/18/2016
Decision Date
08/04/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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