MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES— 510(k) K874952

Name: FDA 510(k) clearance K874952
Creator: U.S. Food and Drug Administration
Published: 1987-12-30

Substantially Equivalent

Solway, Inc.

FDA 510(k) clearance K874952 for MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES, Substantially Equivalent on 1987-12-30. Applicant: Solway, Inc.. Device class: 2.

Clearance details

Applicant: Solway, Inc.
Product code: Code HBG
Device class: Class 2
Regulation: 21 CFR 882.4300
Advisory panel: Neurology
Date received: 1987-12-02
Decision date: 1987-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollywood, FL, US

Download summary PDF View on FDA.gov ↗

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