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FDA 510(k)

BONGORT ILEOSTOMY POUCH

K-Number: K760878 · 1976-12-02

ApplicantHowmedica Corp.
Decision Date1976-12-02
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BONGORT ILEOSTOMY POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1976-12-02 under 510(k) number K760878. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONGORT ILEOSTOMY POUCH?

BONGORT ILEOSTOMY POUCH is a medical device that received FDA 510(k) clearance on 1976-12-02. The listed applicant is Howmedica Corp.. The 510(k) number is K760878.

When did BONGORT ILEOSTOMY POUCH receive FDA 510(k) clearance?

BONGORT ILEOSTOMY POUCH received FDA 510(k) clearance on 1976-12-02, under 510(k) number K760878.

Who is the listed applicant for BONGORT ILEOSTOMY POUCH?

The FDA 510(k) record lists Howmedica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONGORT ILEOSTOMY POUCH?

The FDA product code for BONGORT ILEOSTOMY POUCH is EXB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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