K-number	K011514
Device name	INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
Applicant	Kencap , Ltd.
Product code	KDD
Device class	Class I
Decision date	Aug 13, 2001
Decision	Substantially Equivalent
Regulation	878.4800

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View the full FDA submission: accessdata.fda.gov

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INSTRUMENTS FOR ONE TIME USE - DISPOSABLE

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