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FDA 510(k)

KARAYA GUM POWDER, OSTOMY

K-Number: K770408 · 1977-03-15

ApplicantHowmedica Corp.
Decision Date1977-03-15
Product CodeEZK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARAYA GUM POWDER, OSTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1977-03-15 under 510(k) number K770408. The device is classified under product code EZK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARAYA GUM POWDER, OSTOMY?

KARAYA GUM POWDER, OSTOMY is a medical device that received FDA 510(k) clearance on 1977-03-15. The listed applicant is Howmedica Corp.. The 510(k) number is K770408.

When did KARAYA GUM POWDER, OSTOMY receive FDA 510(k) clearance?

KARAYA GUM POWDER, OSTOMY received FDA 510(k) clearance on 1977-03-15, under 510(k) number K770408.

Who is the listed applicant for KARAYA GUM POWDER, OSTOMY?

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 KARAYA GUM POWDER, OSTOMY?

The FDA product code for KARAYA GUM POWDER, OSTOMY is EZK.

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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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