AUTOMATED BIOPSY DEVICE, MODIFICATION— 510(k) K913815

Name: FDA 510(k) clearance K913815
Creator: U.S. Food and Drug Administration
Published: 1991-10-30

Substantially Equivalent

Hart Enterprises, Inc.

FDA 510(k) clearance K913815 for AUTOMATED BIOPSY DEVICE, MODIFICATION, Substantially Equivalent on 1991-10-30. 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: 1991-08-26
Decision date: 1991-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wyoming, MI, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.