Sapphire Sets— 510(k) K171346

Substantially Equivalent

Icu Medical

FDA 510(k) clearance K171346 for Sapphire Sets, Substantially Equivalent on 2017-08-25. Applicant: Icu Medical.

Clearance details

Applicant: Icu Medical
Product code: Code MRZ
Advisory panel: General Hospital
Date received: 2017-05-08
Decision date: 2017-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, US

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