KOLPLUX SYSTEM— 510(k) K110766

Substantially Equivalent

Kolplast CI Ltda

FDA 510(k) clearance K110766 for KOLPLUX SYSTEM, Substantially Equivalent on 2011-09-15. Applicant: Kolplast CI Ltda.

Clearance details

Applicant: Kolplast CI Ltda
Product code: Code HIB
Advisory panel: Obstetrics/Gynecology
Date received: 2011-03-18
Decision date: 2011-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

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