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FDA 510(k) Application Details - K100356
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K100356
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
POU YU BIOTECHNOLOGY CO., LTD.
NO. 6, FUGONG RD.
FUSING TOWNSHIP, CHANGHUA CTY 506 TW
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Contact
DANIEL TASO
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/12/2010
Decision Date
10/05/2010
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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