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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K091392
Device Name TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK
Applicant
POU YU BIOTECHNOLOGY CO., LTD.
NO. 6, FUGONG RD.
FUSING TOWNSHIP, CHANGHUA CTY,  TW 506
Applicant Contact DANIEL TSAO
Correspondent
POU YU BIOTECHNOLOGY CO., LTD.
NO. 6, FUGONG RD.
FUSING TOWNSHIP, CHANGHUA CTY,  TW 506
Correspondent Contact DANIEL TSAO
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/11/2009
Decision Date 07/30/2009
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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