Flyte— 510(k) K212655

Substantially Equivalent

Pelvital USA, Inc.

FDA 510(k) clearance K212655 for Flyte, Substantially Equivalent on 2021-09-21. Applicant: Pelvital USA, Inc..

Clearance details

Applicant: Pelvital USA, Inc.
Product code: Code HIR
Advisory panel: Obstetrics/Gynecology
Date received: 2021-08-23
Decision date: 2021-09-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

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