TRU-CABLE— 510(k) K063309

Substantially Equivalent

Truphatek International, Ltd.

FDA 510(k) clearance K063309 for TRU-CABLE, Substantially Equivalent on 2007-01-12. Applicant: Truphatek International, Ltd.. Device class: 2.

Clearance details

Applicant: Truphatek International, Ltd.
Product code: Code FFS
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2006-11-02
Decision date: 2007-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, 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.