GUARDIAN URETHRAL SHEATH— 510(k) K141252

Substantially Equivalent

Solace Therapeutics

FDA 510(k) clearance K141252 for GUARDIAN URETHRAL SHEATH, Substantially Equivalent on 2014-06-09. Applicant: Solace Therapeutics. Device class: 2.

Clearance details

Applicant: Solace Therapeutics
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2014-05-14
Decision date: 2014-06-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Farmingham, MA, 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.