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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K022505
Device Name CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,
Applicant
NOUVAG AG
Reusswehrstrasse 1
Gebenstorf,  CH 5412
Applicant Contact ERICH FORSTER
Correspondent
NOUVAG AG
Reusswehrstrasse 1
Gebenstorf,  CH 5412
Correspondent Contact ERICH FORSTER
Regulation Number872.4200
Classification Product Code
EGS  
Date Received07/29/2002
Decision Date 10/01/2003
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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