K-number	K851364
Device name	FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP
Applicant	Precision Dynamics Corp.
Product code	KNW
Device class	Class II
Decision date	Apr 22, 1985
Decision	Substantially Equivalent
Regulation	876.1075

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FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP

Everything you need for a 510(k) submission. Nothing you don't.