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FDA 510(k)

KARAYA GUM PRODUCTS - PROCESS CHANGE

K-Number: K761319 · 1977-02-15

ApplicantHowmedica Corp.
Decision Date1977-02-15
Product CodeEZR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARAYA GUM PRODUCTS - PROCESS CHANGE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1977-02-15 under 510(k) number K761319. 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 KARAYA GUM PRODUCTS - PROCESS CHANGE?

KARAYA GUM PRODUCTS - PROCESS CHANGE is a medical device that received FDA 510(k) clearance on 1977-02-15. The listed applicant is Howmedica Corp.. The 510(k) number is K761319.

When did KARAYA GUM PRODUCTS - PROCESS CHANGE receive FDA 510(k) clearance?

KARAYA GUM PRODUCTS - PROCESS CHANGE received FDA 510(k) clearance on 1977-02-15, under 510(k) number K761319.

Who is the listed applicant for KARAYA GUM PRODUCTS - PROCESS CHANGE?

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 PRODUCTS - PROCESS CHANGE?

The FDA product code for KARAYA GUM PRODUCTS - PROCESS CHANGE 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.K761340OSTOMY KARAYA GUM POWDERHowmedica Corp.K770230KARAYA GUM POWDERAtlantic Surgical

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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