Who is the manufacturer of KARAYA GUM PRODUCTS - PROCESS CHANGE?

Howmedica Corp. filed the 510(k) submission for KARAYA GUM PRODUCTS - PROCESS CHANGE (K761319).

What is the FDA product code for KARAYA GUM PRODUCTS - PROCESS CHANGE?

EZR. It is classified under 21 CFR 876.5900 as a Class 1 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for KARAYA GUM PRODUCTS - PROCESS CHANGE?

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

Who can help prepare an FDA 510(k) submission like KARAYA GUM PRODUCTS - PROCESS CHANGE?

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.

KARAYA GUM PRODUCTS - PROCESS CHANGE

K761319 · Howmedica Corp. · EZR · Feb 15, 1977 · Gastroenterology, Urology

Device Facts

Record ID	K761319
Device Name	KARAYA GUM PRODUCTS - PROCESS CHANGE
Applicant	Howmedica Corp.
Product Code	EZR · Gastroenterology, Urology
Decision Date	Feb 15, 1977
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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