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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 K875255
Device Name DREAM DAM
Applicant
Dental Dam, Inc.
106 Fountain Brook Cir.
P.O. Box 5624
Cary,  NC  27511
Applicant Contact NORMAN GRAY
Correspondent
Dental Dam, Inc.
106 Fountain Brook Cir.
P.O. Box 5624
Cary,  NC  27511
Correspondent Contact NORMAN GRAY
Regulation Number872.6300
Classification Product Code
EIE  
Date Received12/22/1987
Decision Date 03/18/1988
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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