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510(k) K242031

Béa Applicator (BAP-GB-01) by Stepone Fertility Ltd (T/A Béa Fertility) — Product Code HDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2025
Date Received
July 11, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Cervical
Device Class
Class II
Regulation Number
884.5250
Review Panel
OB
Submission Type

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