Who is the manufacturer of FORMULATION CHANGE IN UNITED SKIN BARR?

Howmedica Corp. filed the 510(k) submission for FORMULATION CHANGE IN UNITED SKIN BARR (K810726).

What is the FDA product code for FORMULATION CHANGE IN UNITED SKIN BARR?

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 FORMULATION CHANGE IN UNITED SKIN BARR?

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

Who can help prepare an FDA 510(k) submission like FORMULATION CHANGE IN UNITED SKIN BARR?

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.

FORMULATION CHANGE IN UNITED SKIN BARR

K810726 · Howmedica Corp. · EXB · Jun 2, 1981 · Gastroenterology, Urology

Device Facts

Record ID	K810726
Device Name	FORMULATION CHANGE IN UNITED SKIN BARR
Applicant	Howmedica Corp.
Product Code	EXB · Gastroenterology, Urology
Decision Date	Jun 2, 1981
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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