CABLECAP— 510(k) K113330

Substantially Equivalent

Sensormed

FDA 510(k) clearance K113330 for CABLECAP, Substantially Equivalent on 2012-01-12. Applicant: Sensormed. Device class: 2.

Clearance details

Applicant: Sensormed
Product code: Code FST
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2011-11-14
Decision date: 2012-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, 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.