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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 K874928
Device Name WHOLEY (TM) BIOPSY DEVICE
Applicant
Medrad, Inc.
271 Kappa Dr.
Pittsburgh,  PA  15238
Applicant Contact RUEY C DEMPSEY
Correspondent
Medrad, Inc.
271 Kappa Dr.
Pittsburgh,  PA  15238
Correspondent Contact RUEY C DEMPSEY
Regulation Number878.4800
Classification Product Code
GDM  
Date Received12/02/1987
Decision Date 12/30/1987
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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