KARAYA GUM PRODUCTS - PROCESS CHANGE— 510(k) K761319

Name: FDA 510(k) clearance K761319
Creator: U.S. Food and Drug Administration
Published: 1977-02-15

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K761319 for KARAYA GUM PRODUCTS - PROCESS CHANGE, Substantially Equivalent on 1977-02-15. 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: 1976-12-27
Decision date: 1977-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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