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FDA 510(k)

OSTOMY KARAYA GUM POWDER

K-Number: K761340 · 1977-03-07

ApplicantHowmedica Corp.
Decision Date1977-03-07
Product CodeEZR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OSTOMY KARAYA GUM POWDER is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1977-03-07 under 510(k) number K761340. The device is classified under product code EZR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTOMY KARAYA GUM POWDER?

OSTOMY KARAYA GUM POWDER is a medical device that received FDA 510(k) clearance on 1977-03-07. The listed applicant is Howmedica Corp.. The 510(k) number is K761340.

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

OSTOMY KARAYA GUM POWDER received FDA 510(k) clearance on 1977-03-07, under 510(k) number K761340.

Who is the listed applicant for OSTOMY KARAYA GUM POWDER?

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 OSTOMY KARAYA GUM POWDER?

The FDA product code for OSTOMY KARAYA GUM POWDER is EZR.

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Other records listing Howmedica Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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Related Devices (Code: EZR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K844341UNITED SKIN BARRIER PASTEHowmedica Corp.K803100STOMAHESIVE PASTE PROTECTIVE SKIN BARRE. R. Squibb & Sons, Inc.K791146COLO-TAPESuburban Ostomy Supply Co., Inc.K770230KARAYA GUM POWDERAtlantic SurgicalK761319KARAYA GUM PRODUCTS - PROCESS CHANGEHowmedica Corp.

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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