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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 K864096
Device Name DREAM DAM
Applicant
Dental Dam, Inc.
106 Fountain Brook Circle
P.O. Box 5624
Cary,  NC  27511
Applicant Contact CINDY VERNON
Correspondent
Dental Dam, Inc.
106 Fountain Brook Circle
P.O. Box 5624
Cary,  NC  27511
Correspondent Contact CINDY VERNON
Regulation Number872.6300
Classification Product Code
EIE  
Date Received10/21/1986
Decision Date 11/18/1986
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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