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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 K883876
Device Name WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE
Applicant
E.G. Dick & Assoc.
7527 Westmoreland Ave.
St Louis,  MO  63105
Applicant Contact DICK, PH.D.
Correspondent
E.G. Dick & Assoc.
7527 Westmoreland Ave.
St Louis,  MO  63105
Correspondent Contact DICK, PH.D.
Regulation Number878.4800
Classification Product Code
GDM  
Date Received09/13/1988
Decision Date 10/07/1988
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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