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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 K022522
Device Name PULPDENT PUTTY DAM
Applicant
Pulpdent Corporation
80 Oakland St.
Watertown,  MA  02472
Applicant Contact KENNETH J BERK
Correspondent
Pulpdent Corporation
80 Oakland St.
Watertown,  MA  02472
Correspondent Contact KENNETH J BERK
Regulation Number872.6300
Classification Product Code
EIE  
Date Received07/30/2002
Decision Date 09/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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