BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.— 510(k) K771725

Name: FDA 510(k) clearance K771725
Creator: U.S. Food and Drug Administration
Published: 1977-09-26

Substantially Equivalent

Xomed, Inc.

FDA 510(k) clearance K771725 for BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE., Substantially Equivalent on 1977-09-26. Applicant: Xomed, Inc.. Device class: 1.

Clearance details

Applicant: Xomed, Inc.
Product code: Code FEX
Device class: Class 1
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1977-09-13
Decision date: 1977-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arnold, MO, US

Download summary PDF View on FDA.gov ↗

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