KARAYA GUM POWDER, OSTOMY— 510(k) K770408

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K770408 for KARAYA GUM POWDER, OSTOMY, Substantially Equivalent on 1977-03-15. Applicant: Howmedica Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Corp.
Product code: Code EZK
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1977-03-04
Decision date: 1977-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.