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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 K851364
Device Name FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP
Applicant
Precision Dynamics Corp.
3031 Thornton Ave.
Burbank,  CA  91504
Applicant Contact DAVID L KING
Correspondent
Precision Dynamics Corp.
3031 Thornton Ave.
Burbank,  CA  91504
Correspondent Contact DAVID L KING
Regulation Number876.1075
Classification Product Code
KNW  
Date Received04/04/1985
Decision Date 04/22/1985
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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