K-number	K230408
Device name	K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
Applicant	Sb-Kawasumi Laboratories, Inc.
Product code	JKA
Device class	Class II
Decision date	Jun 1, 2023
Decision	Substantially Equivalent
Regulation	862.1675

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View the full FDA submission: accessdata.fda.gov

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K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)

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