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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 K091026
Device Name TDS ABUTMENT FOR NOBEL BIOCARE REPLACE
Applicant
Pou YU Biotechnology Co., Ltd.
# 6, Fugong Rd.
Fusing Township, Changhua Cty,  TW 506
Applicant Contact DANIEL TSAO
Correspondent
Pou YU Biotechnology Co., Ltd.
# 6, Fugong Rd.
Fusing Township, Changhua Cty,  TW 506
Correspondent Contact DANIEL TSAO
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/10/2009
Decision Date 06/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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