C-TRAK BIOPSY SYSTEM— 510(k) K922117

Name: FDA 510(k) clearance K922117
Creator: U.S. Food and Drug Administration
Published: 1992-10-14

Substantially Equivalent

Care Wise Medical Products Corp.

FDA 510(k) clearance K922117 for C-TRAK BIOPSY SYSTEM, Substantially Equivalent on 1992-10-14. Applicant: Care Wise Medical Products Corp.. Device class: 1.

Clearance details

Applicant: Care Wise Medical Products Corp.
Product code: Code IZD
Device class: Class 1
Regulation: 21 CFR 892.1320
Advisory panel: Radiology
Date received: 1992-05-05
Decision date: 1992-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgan Hill, CA, US

Download summary PDF View on FDA.gov ↗

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