RONGEUR (NEUROSURGICAL INSTRUMENTS)— 510(k) K875043

Name: FDA 510(k) clearance K875043
Creator: U.S. Food and Drug Administration
Published: 1988-01-22

Substantially Equivalent

Solway, Inc.

FDA 510(k) clearance K875043 for RONGEUR (NEUROSURGICAL INSTRUMENTS), Substantially Equivalent on 1988-01-22. Applicant: Solway, Inc.. Device class: 2.

Clearance details

Applicant: Solway, Inc.
Product code: Code HAE
Device class: Class 2
Regulation: 21 CFR 882.4840
Advisory panel: Neurology
Date received: 1987-12-02
Decision date: 1988-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollywood, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.