OSTOMY KARAYA GUM POWDER— 510(k) K761340

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K761340 for OSTOMY KARAYA GUM POWDER, Substantially Equivalent on 1977-03-07. Applicant: Howmedica Corp.. Device class: 1.

Clearance details

Applicant: Howmedica Corp.
Product code: Code EZR
Device class: Class 1
Regulation: 21 CFR 876.5900
Advisory panel: Gastroenterology, Urology
Date received: 1976-12-28
Decision date: 1977-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EZR

K844341 — UNITED SKIN BARRIER PASTE1985-01-18
K803100 — STOMAHESIVE PASTE PROTECTIVE SKIN BARR1981-01-08
K791146 — COLO-TAPE1979-07-30
K770230 — KARAYA GUM POWDER1977-02-28
K761319 — KARAYA GUM PRODUCTS - PROCESS CHANGE1977-02-15

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K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION1998-12-16
K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION1998-12-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.