Who is the manufacturer of FEATHER-LITE URINARY DIV. POUCH?

Howmedica Corp. filed the 510(k) submission for FEATHER-LITE URINARY DIV. POUCH (K792139).

What is the FDA product code for FEATHER-LITE URINARY DIV. POUCH?

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 FEATHER-LITE URINARY DIV. POUCH?

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

Who can help prepare an FDA 510(k) submission like FEATHER-LITE URINARY DIV. POUCH?

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.

FEATHER-LITE URINARY DIV. POUCH

K792139 · Howmedica Corp. · EXB · Nov 13, 1979 · Gastroenterology, Urology

Device Facts

Record ID	K792139
Device Name	FEATHER-LITE URINARY DIV. POUCH
Applicant	Howmedica Corp.
Product Code	EXB · Gastroenterology, Urology
Decision Date	Nov 13, 1979
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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