Question 1

Who is the manufacturer of GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09?

Accepted Answer

Gebauer Co. filed the 510(k) submission for GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 (K002596).

Question 2

What is the FDA product code for GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09?

Accepted Answer

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

Question 3

When was GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 cleared by the FDA?

Accepted Answer

Feb 15, 2001 (decision: SESE).

Question 4

What is the regulatory pathway for GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09?

Accepted Answer

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.

Record ID	K002596
Device Name	GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
Applicant	Gebauer Co.
Product Code	MLY · PM
Decision Date	Feb 15, 2001
Decision	SESE
Submission Type	Traditional
Device Class	Class U

GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09

Device Facts