BIOGEL ORTHOPRO INDICATOR UNDERGLOVE— 510(k) K101163

Name: FDA 510(k) clearance K101163
Creator: U.S. Food and Drug Administration
Published: 2010-11-23

Substantially Equivalent

Molnlycke Health Care USA

FDA 510(k) clearance K101163 for BIOGEL ORTHOPRO INDICATOR UNDERGLOVE, Substantially Equivalent on 2010-11-23. Applicant: Molnlycke Health Care USA. Device class: 1.

Clearance details

Applicant: Molnlycke Health Care USA
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2010-04-26
Decision date: 2010-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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