K-number	K223620
Device name	Reprieve by RegenesisTM
Applicant	Regenesis Biomedical, Inc.
Product code	IMJ
Device class	Class II
Decision date	May 24, 2023
Decision	Substantially Equivalent
Regulation	890.5290

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Source

View the full FDA submission: accessdata.fda.gov

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Reprieve by RegenesisTM

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