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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cement, ear, nose and throat
510(k) Number K003567
Device Name SERENOCEM, MODEL BC 010
Applicant
CORINTHIAN MEDICAL LTD.
AMSTEL 320-1
amerstdam,  NL 1017 ap
Applicant Contact dagmar maser
Correspondent
CORINTHIAN MEDICAL LTD.
AMSTEL 320-1
amerstdam,  NL 1017 ap
Correspondent Contact dagmar maser
Regulation Number872.3275
Classification Product Code
NEA  
Date Received11/20/2000
Decision Date 02/12/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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