ARTHROPLASTY MALLET— 510(k) K872209

Name: FDA 510(k) clearance K872209
Creator: U.S. Food and Drug Administration
Published: 1987-06-23

Substantially Equivalent

New England Surgical Instrument Corp.

FDA 510(k) clearance K872209 for ARTHROPLASTY MALLET, Substantially Equivalent on 1987-06-23. Applicant: New England Surgical Instrument Corp.. Device class: 1.

Clearance details

Applicant: New England Surgical Instrument Corp.
Product code: Code HXL
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1987-06-09
Decision date: 1987-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

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