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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Retentive And Splinting, And Accessory Instruments
510(k) Number K002693
Device Name CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
Applicant
CBS INTL. B.V.
GROTE MARKET 3-5
ALMERE,  NL 1315 JA
Applicant Contact PATRICIA E JANSEN
Correspondent
CBS INTL. B.V.
GROTE MARKET 3-5
ALMERE,  NL 1315 JA
Correspondent Contact PATRICIA E JANSEN
Regulation Number872.3740
Classification Product Code
EBL  
Date Received08/29/2000
Decision Date 11/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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