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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical
510(k) Number K874665
Device Name SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY
Applicant
Precision Dynamics Corp.
Post Office Box 9043
Van Nuys,  CA  91409
Applicant Contact GINO FRANCO
Correspondent
Precision Dynamics Corp.
Post Office Box 9043
Van Nuys,  CA  91409
Correspondent Contact GINO FRANCO
Regulation Number878.4800
Classification Product Code
LRP  
Date Received11/13/1987
Decision Date 01/20/1988
Decision Substantially Equivalent - With Drug (SESD)
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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