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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 K021613
Device Name NIVEOUS LIQUID DAM
Applicant
Shofu Dental Corp.
1225 Stone Dr.
San Marcos,  CA  92078
Applicant Contact ROBERT NOBLE
Correspondent
Shofu Dental Corp.
1225 Stone Dr.
San Marcos,  CA  92078
Correspondent Contact ROBERT NOBLE
Regulation Number872.6300
Classification Product Code
EIE  
Date Received05/16/2002
Decision Date 06/20/2002
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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