SMOOTHSHAPES— 510(k) K083629

Substantially Equivalent

Eleme Medical, Inc.

FDA 510(k) clearance K083629 for SMOOTHSHAPES, Substantially Equivalent on 2009-02-19. Applicant: Eleme Medical, Inc.. Device class: 2.

Clearance details

Applicant: Eleme Medical, Inc.
Product code: Code NUV
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2008-12-08
Decision date: 2009-02-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Merrimack, NH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Eleme Medical, Inc.

K100230 — SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V2010-04-02
K083478 — SMOOTHLIPO2009-03-17

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