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510(k) K193364

Intimate Rose Kegel Exercise System by Plus EV Holdings Dba Intimate Rose — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2020
Date Received
December 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perineometer
Device Class
Class II
Regulation Number
884.1425
Review Panel
GU
Submission Type

Other clearances by Plus EV Holdings Dba Intimate Rose

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  • K212655 — Flyte (September 21, 2021)
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