K-number	K213120
Device name	OW100S (model OW100S-US)
Applicant	Tissue Regeneration Technologies, LLC Dba AS Softwave Trt
Product code	ISA
Device class	Class I
Decision date	Oct 12, 2022
Decision	Substantially Equivalent
Regulation	890.5660

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Source

View the full FDA submission: accessdata.fda.gov

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OW100S (model OW100S-US)

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