Name: Predicase
Price: 199 USD

K-number	K060655
Device name	SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H
Applicant	Biotronik, Inc.
Product code	DQY
Device class	Class II
Decision date	Apr 4, 2006
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H

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