K-number	K201518
Device name	Route 92 Medical 088 Access System
Applicant	Route 92 Medical
Product code	QJP
Device class	Class II
Decision date	Aug 14, 2020
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Route 92 Medical 088 Access System

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