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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K863834
Device Name EVIDENT MARK 2 APEX LOCATOR
Applicant
Pulpdent Corp. of America
75 Boylston St.
P.O. Box 689
Brookline,  MA  02147
Applicant Contact FREDRICK M BERK
Correspondent
Pulpdent Corp. of America
75 Boylston St.
P.O. Box 689
Brookline,  MA  02147
Correspondent Contact FREDRICK M BERK
Date Received09/30/1986
Decision Date 02/06/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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