K-number	K152090
Device name	Reprocessed Steerable Introducer
Applicant	Sterilmed, Inc.
Product code	PNE
Device class	Class II
Decision date	Mar 23, 2016
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed Steerable Introducer

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