Who is the manufacturer of BONGORT SPECIAL ODORPROOF DRAIN?

Howmedica Corp. filed the 510(k) submission for BONGORT SPECIAL ODORPROOF DRAIN (K760735).

What is the FDA product code for BONGORT SPECIAL ODORPROOF DRAIN?

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 BONGORT SPECIAL ODORPROOF DRAIN?

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

Who can help prepare an FDA 510(k) submission like BONGORT SPECIAL ODORPROOF DRAIN?

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.

BONGORT SPECIAL ODORPROOF DRAIN

K760735 · Howmedica Corp. · EXB · Oct 15, 1976 · Gastroenterology, Urology

Device Facts

Record ID	K760735
Device Name	BONGORT SPECIAL ODORPROOF DRAIN
Applicant	Howmedica Corp.
Product Code	EXB · Gastroenterology, Urology
Decision Date	Oct 15, 1976
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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