MATTIOLI PULSE TWO/THREE PLUS FAMILY— 510(k) K100053

Name: FDA 510(k) clearance K100053
Creator: U.S. Food and Drug Administration
Published: 2010-03-10

Substantially Equivalent

Mattioli Engineering Corp.

FDA 510(k) clearance K100053 for MATTIOLI PULSE TWO/THREE PLUS FAMILY, Substantially Equivalent on 2010-03-10. Applicant: Mattioli Engineering Corp.. Device class: 2.

Clearance details

Applicant: Mattioli Engineering Corp.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2010-01-08
Decision date: 2010-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mclean, VA, US

Download summary PDF View on FDA.gov ↗

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