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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K891607
Device Name DENTANURSE
Applicant
The Irish Scene
P.O. Box 3602
Stamford,  CT  06905
Applicant Contact JAMES WHELAN
Correspondent
The Irish Scene
P.O. Box 3602
Stamford,  CT  06905
Correspondent Contact JAMES WHELAN
Regulation Number872.3275
Classification Product Code
EMA  
Date Received03/20/1989
Decision Date 08/11/1989
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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