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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Reusable
510(k) Number K882601
Device Name E-Z-EM(R) LUFKIN BIOPSY NEEDLES
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
Regulation Number878.4800
Classification Product Code
GDM  
Date Received06/24/1988
Decision Date 07/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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