MEDICOOL (MODIFICATON)— 510(k) K954095

Name: FDA 510(k) clearance K954095
Creator: U.S. Food and Drug Administration
Published: 1996-03-06

Substantially Equivalent for Some Indications

Microclimate Systems, Inc.

FDA 510(k) clearance K954095 for MEDICOOL (MODIFICATON), Substantially Equivalent for Some Indications on 1996-03-06. Applicant: Microclimate Systems, Inc.. Device class: 2.

Clearance details

Applicant: Microclimate Systems, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1995-08-20
Decision date: 1996-03-06
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Sanford, MI, US

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