BICARB MIXING AND DISTRIBUTION SYSTEM— 510(k) K112427

Substantially Equivalent

Isopure, Corp.

FDA 510(k) clearance K112427 for BICARB MIXING AND DISTRIBUTION SYSTEM, Substantially Equivalent on 2012-01-26. Applicant: Isopure, Corp..

Clearance details

Applicant: Isopure, Corp.
Product code: Code FIN
Advisory panel: Gastroenterology, Urology
Date received: 2011-08-23
Decision date: 2012-01-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Simpsonville, KY, US

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