MALLEABLE PTFE COATED BRAIN SPATULAE— 510(k) K880278

Name: FDA 510(k) clearance K880278
Creator: U.S. Food and Drug Administration
Published: 1988-02-11

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K880278 for MALLEABLE PTFE COATED BRAIN SPATULAE, Substantially Equivalent on 1988-02-11. Applicant: Downs Surgical , Ltd.. Device class: 1.

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code HAO
Device class: Class 1
Regulation: 21 CFR 882.4535
Advisory panel: Neurology
Date received: 1988-01-22
Decision date: 1988-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheffield S9 4wj, GB

Download summary PDF View on FDA.gov ↗

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