Name: Predicase
Price: 199 USD

K-number	K062072
Device name	PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES
Applicant	PAJUNK GmbH Medizintechnologie
Product code	GEI
Device class	Class II
Decision date	Sep 22, 2006
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES

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