BIOGEL (R) INDICATOR (R) UNDERGLOVE— 510(k) K111413

Substantially Equivalent

Molnlycke Health Care Us, LLC

FDA 510(k) clearance K111413 for BIOGEL (R) INDICATOR (R) UNDERGLOVE, Substantially Equivalent on 2012-01-30. Applicant: Molnlycke Health Care Us, LLC.

Clearance details

Applicant: Molnlycke Health Care Us, LLC
Product code: Code KGO
Advisory panel: General, Plastic Surgery
Date received: 2011-05-20
Decision date: 2012-01-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Norcross, GA, US

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