NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE— 510(k) K885149

Name: FDA 510(k) clearance K885149
Creator: U.S. Food and Drug Administration
Published: 1989-01-26

Substantially Equivalent

Hart Enterprises, Inc.

FDA 510(k) clearance K885149 for NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE, Substantially Equivalent on 1989-01-26. Applicant: Hart Enterprises, Inc.. Device class: 1.

Clearance details

Applicant: Hart Enterprises, Inc.
Product code: Code DWO
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1988-12-15
Decision date: 1989-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wyoming, MI, US

Download summary PDF View on FDA.gov ↗

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K885145 — MEDSURG GREENE NEEDLE1989-03-14

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