E-Z Lubricating Jelly

• • Terminated Z-0984-2017 FDA Class II ·initiated 12 Dec 2016

  Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company.

510(k) Number

K041060 ↗

FDA Product Code

KMJ

Device Class

Class I

Regulation

21 CFR Part 880.6375

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• Modification to Statsign Saline Electrolyte Gel, Graham-Field Saline Electrolyte Gel

  Class II

  FDA 510(k) K001593 Active Cleared 14 Jun 2000

See all devices from Chester Labs, Inc. →