TROTEX II SCREW NEEDLE BIOPSY INSTR. SET— 510(k) K792316

Name: FDA 510(k) clearance K792316
Creator: U.S. Food and Drug Administration
Published: 1979-12-18

Substantially Equivalent

Ursus Konsult AB

FDA 510(k) clearance K792316 for TROTEX II SCREW NEEDLE BIOPSY INSTR. SET, Substantially Equivalent on 1979-12-18. Applicant: Ursus Konsult AB. Device class: 1.

Clearance details

Applicant: Ursus Konsult AB
Product code: Code GEE
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1979-11-16
Decision date: 1979-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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