STERILE SOFT TISSUE BIOPSY NEEDLE— 510(k) K854003

Name: FDA 510(k) clearance K854003
Creator: U.S. Food and Drug Administration
Published: 1985-10-18

Substantially Equivalent

Co-Medical, Inc.

FDA 510(k) clearance K854003 for STERILE SOFT TISSUE BIOPSY NEEDLE, Substantially Equivalent on 1985-10-18. Applicant: Co-Medical, Inc.. Device class: 1.

Clearance details

Applicant: Co-Medical, Inc.
Product code: Code GEE
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1985-09-30
Decision date: 1985-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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