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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 K100356
Device Name TDS PRECISION DENTAL BAR
Applicant
POU YU BIOTECHNOLOGY CO., LTD.
NO. 6, FUGONG RD.
FUSING TOWNSHIP, CHANGHUA CTY,  TW 506
Applicant Contact DANIEL TASO
Correspondent
POU YU BIOTECHNOLOGY CO., LTD.
NO. 6, FUGONG RD.
FUSING TOWNSHIP, CHANGHUA CTY,  TW 506
Correspondent Contact DANIEL TASO
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/12/2010
Decision Date 10/05/2010
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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