SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V— 510(k) K100230

Substantially Equivalent

Eleme Medical, Inc.

FDA 510(k) clearance K100230 for SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V, Substantially Equivalent on 2010-04-02. Applicant: Eleme Medical, Inc..

Clearance details

Applicant: Eleme Medical, Inc.
Product code: Code NUV
Advisory panel: General, Plastic Surgery
Date received: 2010-01-26
Decision date: 2010-04-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Merrimack, NH, US

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