K110766

Substantially Equivalent

KOLPLUX SYSTEM

Applicant: Kolplast CI Ltda
Product 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

Download summary PDF View on FDA.gov ↗

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