BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN— 510(k) K915800

Name: FDA 510(k) clearance K915800
Creator: U.S. Food and Drug Administration
Published: 1992-03-16

Substantially Equivalent

Bremer Medical, Inc.

FDA 510(k) clearance K915800 for BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN, Substantially Equivalent on 1992-03-16. Applicant: Bremer Medical, Inc.. Device class: 2.

Clearance details

Applicant: Bremer Medical, Inc.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1991-12-24
Decision date: 1992-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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