J105 JAMES SURGICAL SYSTEM I/A PACK— 510(k) K911932

Name: FDA 510(k) clearance K911932
Creator: U.S. Food and Drug Administration
Published: 1991-08-26

Substantially Equivalent

O.R. Specialties, Inc.

FDA 510(k) clearance K911932 for J105 JAMES SURGICAL SYSTEM I/A PACK, Substantially Equivalent on 1991-08-26. Applicant: O.R. Specialties, Inc.. Device class: 1.

Clearance details

Applicant: O.R. Specialties, Inc.
Product code: Code GZX
Device class: Class 1
Regulation: 21 CFR 882.4525
Advisory panel: Neurology
Date received: 1991-04-30
Decision date: 1991-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuscaloosa, AL, US

Download summary PDF View on FDA.gov ↗

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