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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, Disposable
510(k) Number K771784
Device Name IOPSY TRAY FOR SOFT TISSUE BIOPSY
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Regulation Number878.4800
Classification Product Code
GAA  
Date Received09/23/1977
Decision Date 11/30/1977
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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