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FDA 510(k) Application Details - K081460
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K081460
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
POU YU BIOTECHNOLOGY CO., LTD.
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO, CA 92130 US
Other 510(k) Applications for this Company
Contact
LINDA K SCHULZ
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
05/23/2008
Decision Date
11/21/2008
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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