NEUROSURGICAL INSTURMENTS (VARIOUS)— 510(k) K861630

Name: FDA 510(k) clearance K861630
Creator: U.S. Food and Drug Administration
Published: 1986-05-09

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K861630 for NEUROSURGICAL INSTURMENTS (VARIOUS), Substantially Equivalent on 1986-05-09. 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: 1986-04-29
Decision date: 1986-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, US

Download summary PDF View on FDA.gov ↗

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