OSMOCEL +— 510(k) K830188

Substantially Equivalent

Hematology Marketing Assoc.

FDA 510(k) clearance K830188 for OSMOCEL +, Substantially Equivalent on 1983-03-01. Applicant: Hematology Marketing Assoc.. Device class: 1.

Clearance details

Applicant: Hematology Marketing Assoc.
Product code: Code GIF
Device class: Class 1
Regulation: 21 CFR 864.8200
Advisory panel: Hematology
Date received: 1983-01-19
Decision date: 1983-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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