SKELETAL DYNAMICS STERILIZATION TRAYS— 510(k) K102103

Name: FDA 510(k) clearance K102103
Creator: U.S. Food and Drug Administration
Published: 2010-12-07

Substantially Equivalent

Skeletal Dynamics, LLC

FDA 510(k) clearance K102103 for SKELETAL DYNAMICS STERILIZATION TRAYS, Substantially Equivalent on 2010-12-07. Applicant: Skeletal Dynamics, LLC. Device class: 2.

Clearance details

Applicant: Skeletal Dynamics, LLC
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2010-07-27
Decision date: 2010-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.