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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 K852630
Device Name DEN-MAT PAINT-ON RUBBER DAM
Applicant
Den-Mat Corp.
P.O. Box 1729
Santa Maria,  CA  93456
Applicant Contact ROBERT L IBSEN
Correspondent
Den-Mat Corp.
P.O. Box 1729
Santa Maria,  CA  93456
Correspondent Contact ROBERT L IBSEN
Regulation Number872.6300
Classification Product Code
EIE  
Date Received06/20/1985
Decision Date 12/18/1985
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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