Who is the manufacturer of OSTOMY APPLIANCE W/DEODORIZING FILTER?

Hollister, Inc. filed the 510(k) submission for OSTOMY APPLIANCE W/DEODORIZING FILTER (K781373).

What is the FDA product code for OSTOMY APPLIANCE W/DEODORIZING FILTER?

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 OSTOMY APPLIANCE W/DEODORIZING FILTER?

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

Who can help prepare an FDA 510(k) submission like OSTOMY APPLIANCE W/DEODORIZING FILTER?

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.

OSTOMY APPLIANCE W/DEODORIZING FILTER

K781373 · Hollister, Inc. · EXB · Sep 20, 1978 · Gastroenterology, Urology

Device Facts

Record ID	K781373
Device Name	OSTOMY APPLIANCE W/DEODORIZING FILTER
Applicant	Hollister, Inc.
Product Code	EXB · Gastroenterology, Urology
Decision Date	Sep 20, 1978
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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