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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K923020
Device Name CLEANIC
Applicant
Hawe Neos Dental
Dr.. H.V. Weissenfluh Ag
Ch 6934 Bioggio
Switzerland,  CH
Applicant Contact ULRICH HUBLER
Correspondent
Hawe Neos Dental
Dr.. H.V. Weissenfluh Ag
Ch 6934 Bioggio
Switzerland,  CH
Correspondent Contact ULRICH HUBLER
Regulation Number872.6030
Classification Product Code
EJR  
Date Received06/23/1992
Decision Date 09/09/1992
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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