Who is the manufacturer of HOLLISTER CATHETER ACCESS. PORT?

Hollister, Inc. filed the 510(k) submission for HOLLISTER CATHETER ACCESS. PORT (K821680).

What is the FDA product code for HOLLISTER CATHETER ACCESS. PORT?

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 CATHETER ACCESS. PORT?

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

Who can help prepare an FDA 510(k) submission like HOLLISTER CATHETER ACCESS. PORT?

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 CATHETER ACCESS. PORT

K821680 · Hollister, Inc. · EXB · Jun 24, 1982 · Gastroenterology, Urology

Device Facts

Record ID	K821680
Device Name	HOLLISTER CATHETER ACCESS. PORT
Applicant	Hollister, Inc.
Product Code	EXB · Gastroenterology, Urology
Decision Date	Jun 24, 1982
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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