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FDA 510(k) Application Details - K132067
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K132067
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
HIOSSEN INC.
85 BEN FAIRLESS DRIVE
FAIRLESS HILLS, PA 19030 US
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Contact
PATRICK LIM
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Regulation Number
872.3630
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Classification Product Code
NHA
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More FDA Info for this Product Code
Date Received
07/03/2013
Decision Date
12/20/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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