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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K873369
Device Name SECURLINE FRANSEENE NEEDLE
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 Number876.1075
Classification Product Code
KNW  
Date Received08/21/1987
Decision Date 10/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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