OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION— 510(k) K961725

Name: FDA 510(k) clearance K961725
Creator: U.S. Food and Drug Administration
Published: 1996-08-01

Substantially Equivalent

C.L. Mcintosh & Assoc., Inc.

FDA 510(k) clearance K961725 for OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION, Substantially Equivalent on 1996-08-01. Applicant: C.L. Mcintosh & Assoc., Inc.. Device class: 2.

Clearance details

Applicant: C.L. Mcintosh & Assoc., Inc.
Product code: Code JDX
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 1996-05-03
Decision date: 1996-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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