K-number	K231063
Device name	SOMAVAC® 100 Sustained Vacuum System
Applicant	Somavac Medical Solutions, Inc.
Product code	BTA
Device class	Class II
Decision date	May 12, 2023
Decision	Substantially Equivalent
Regulation	878.4780

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Source

View the full FDA submission: accessdata.fda.gov

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SOMAVAC® 100 Sustained Vacuum System

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