VR101 Lubricating Intravaginal Ring— 510(k) K203377

Name: FDA 510(k) clearance K203377
Creator: U.S. Food and Drug Administration
Published: 2021-05-20

Substantially Equivalent

J3 Bioscience, Inc.

FDA 510(k) clearance K203377 for VR101 Lubricating Intravaginal Ring, Substantially Equivalent on 2021-05-20. Applicant: J3 Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: J3 Bioscience, Inc.
Product code: Code QPD
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2020-11-17
Decision date: 2021-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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