Omni Prep Gel

FDA 510(k) K933797 · Cadwell Laboratories, Inc.

Substantially Equivalent

510(k) numberK933797

Submission

Device name
Omni Prep Gel
Applicant
Cadwell Laboratories, Inc.
Kennewick, WA, US
Received
August 4, 1993
Decision date
May 17, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GYB – Media, Electroconductive
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1275
Specialty
Neurology

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Questions and answers

When was Omni Prep Gel cleared by the FDA?

Omni Prep Gel (K933797) received a 510(k) decision of Substantially Equivalent on May 17, 1994, 286 days after the submission was received.

What is the product code of K933797?

The FDA product code is GYB – Media, Electroconductive, a Class II (moderate risk) device regulated under 21 CFR 882.1275.