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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dam, Rubber
510(k) Number K894120
Device Name MADEGOM LTDA. DENTAL DAM
Applicant
Madegom
Casilla Postal 85
11 Santiago
Chile,  CL
Applicant Contact ALEJANDRO MIRALLES
Correspondent
Madegom
Casilla Postal 85
11 Santiago
Chile,  CL
Correspondent Contact ALEJANDRO MIRALLES
Regulation Number872.6300
Classification Product Code
EIE  
Date Received06/12/1989
Decision Date 08/21/1989
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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