NEODYNE DRESSING— 510(k) K112131

Substantially Equivalent

Neodyne Biosciences, Inc.

FDA 510(k) clearance K112131 for NEODYNE DRESSING, Substantially Equivalent on 2011-09-29. Applicant: Neodyne Biosciences, Inc.. Device class: 1.

Clearance details

Applicant: Neodyne Biosciences, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 2011-07-26
Decision date: 2011-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, 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.