Who is the manufacturer of BANGORT LIFESTYLE COLOSTOMY POUCHES?

Howmedica Corp. filed the 510(k) submission for BANGORT LIFESTYLE COLOSTOMY POUCHES (K841029).

What is the FDA product code for BANGORT LIFESTYLE COLOSTOMY POUCHES?

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

What is the regulatory pathway for BANGORT LIFESTYLE COLOSTOMY POUCHES?

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

Who can help prepare an FDA 510(k) submission like BANGORT LIFESTYLE COLOSTOMY POUCHES?

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.

BANGORT LIFESTYLE COLOSTOMY POUCHES

K841029 · Howmedica Corp. · EXB · Apr 4, 1984 · Gastroenterology, Urology

Device Facts

Record ID	K841029
Device Name	BANGORT LIFESTYLE COLOSTOMY POUCHES
Applicant	Howmedica Corp.
Product Code	EXB · Gastroenterology, Urology
Decision Date	Apr 4, 1984
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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