Who is the manufacturer of HOLLISTER STOMA POUCH WITH MICRO ADHES?

Hollister, Inc. filed the 510(k) submission for HOLLISTER STOMA POUCH WITH MICRO ADHES (K791535).

What is the FDA product code for HOLLISTER STOMA POUCH WITH MICRO ADHES?

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 HOLLISTER STOMA POUCH WITH MICRO ADHES?

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

Who can help prepare an FDA 510(k) submission like HOLLISTER STOMA POUCH WITH MICRO ADHES?

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.

HOLLISTER STOMA POUCH WITH MICRO ADHES

K791535 · Hollister, Inc. · EXB · Oct 26, 1979 · Gastroenterology, Urology

Device Facts

Record ID	K791535
Device Name	HOLLISTER STOMA POUCH WITH MICRO ADHES
Applicant	Hollister, Inc.
Product Code	EXB · Gastroenterology, Urology
Decision Date	Oct 26, 1979
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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