
Lujena, Inc.
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Hope&Her Vaginal Dilators is an FDA 510(k)-cleared medical device (K222492) manufactured by Lujena, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 26, 2023. Regulation: 8.

Ansell
SKU MSC846624

Princeton BioMeditech Corp.
SKU K014192

McKesson
SKU VM-1270030

Hollister
SKU VM-1270031