K-number	K213718
Device name	SOL-GUARD Safety Pull Button Collection Set
Applicant	Sol-Millennium Medical, Inc.
Product code	JKA
Device class	Class II
Decision date	Aug 30, 2022
Decision	Substantially Equivalent
Regulation	862.1675

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Source

View the full FDA submission: accessdata.fda.gov

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SOL-GUARD Safety Pull Button Collection Set

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