Who is the manufacturer of GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04?

Gebauer Co. filed the 510(k) submission for GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 (K001624).

What is the FDA product code for GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04?

MLY. as a Class U device in the PM panel.

What is the regulatory pathway for GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04

K001624 · Gebauer Co. · MLY · Jan 25, 2001 · PM

Device Facts

Record ID	K001624
Device Name	GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04
Applicant	Gebauer Co.
Product Code	MLY · PM
Decision Date	Jan 25, 2001
Decision	SESE
Submission Type	Traditional
Device Class	Class U

GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04

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GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04

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