INSTRUMENT CASSETTE (EFCCL1-F)— 510(k) K141854

Name: FDA 510(k) clearance K141854
Creator: U.S. Food and Drug Administration
Published: 2015-10-29

Substantially Equivalent

Osung Mnd Co., Ltd.

FDA 510(k) clearance K141854 for INSTRUMENT CASSETTE (EFCCL1-F), Substantially Equivalent on 2015-10-29. Applicant: Osung Mnd Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osung Mnd Co., Ltd.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2014-07-09
Decision date: 2015-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpentersville, IL, US

Download summary PDF View on FDA.gov ↗

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