Empelvic SM 3160

Trade name

Empelvic

Generic name

Custom-made cushion

Model / reference

SM 3160

Primary DI / UDI-DI

00384703160019

FDA product code

ION

GMDN term

Custom-made cushion

Device class

Class I

Regulation number

890.5370

GUDID distribution status

In Commercial Distribution

Category: Custom-made cushion

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  FDA 510(k) K223854 Active Cleared 30 Jun 2023 GUDID on market

• Unifine Pentips Plus AN 0860SB3 Open recall

  Class II

  FDA 510(k) K152339 Active Cleared 24 Jun 2016 GUDID on market

See all devices from Owen Mumford USA Incorporated →