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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853667
Device Name BRONCHIAL CYTOLOGY BRUSH
Applicant
E-Z-Em, Inc.
717 Main St.
Westbury,  NY  11590
Applicant Contact JACK T BERGER
Correspondent
E-Z-Em, Inc.
717 Main St.
Westbury,  NY  11590
Correspondent Contact JACK T BERGER
Date Received09/03/1985
Decision Date 12/18/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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