K-number	K971498
Device name	APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
Applicant	Applied Medical Resources
Product code	EZB
Device class	Class I
Decision date	May 5, 1997
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE

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