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..

Clearance details

Applicant: Eleme Medical, Inc.
Product code: Code NUV
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

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