OSTEOSCAF— 510(k) K101827

Name: FDA 510(k) clearance K101827
Creator: U.S. Food and Drug Administration
Published: 2011-04-20

Substantially Equivalent

Texas Innovative Medical Devices (Dba) Skeletal

FDA 510(k) clearance K101827 for OSTEOSCAF, Substantially Equivalent on 2011-04-20. Applicant: Texas Innovative Medical Devices (Dba) Skeletal. Device class: 2.

Clearance details

Applicant: Texas Innovative Medical Devices (Dba) Skeletal
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2010-07-01
Decision date: 2011-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, 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.