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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K970827
Device Name PRECISE
Applicant
Allan Schulman,D.D.S., M.S.
138-40 78th Rd.
Flushing,  NY  11367
Applicant Contact ALLAN SCHULMAN
Correspondent
Allan Schulman,D.D.S., M.S.
138-40 78th Rd.
Flushing,  NY  11367
Correspondent Contact ALLAN SCHULMAN
Regulation Number872.3710
Classification Product Code
EJH  
Date Received03/06/1997
Decision Date 04/16/1997
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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