DANA 3CC SYRINGE INSULIN RESERVOIR— 510(k) K071418

Name: FDA 510(k) clearance K071418
Creator: U.S. Food and Drug Administration
Published: 2007-09-04

Substantially Equivalent

Sooil Development Co., Ltd.

FDA 510(k) clearance K071418 for DANA 3CC SYRINGE INSULIN RESERVOIR, Substantially Equivalent on 2007-09-04. Applicant: Sooil Development Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sooil Development Co., Ltd.
Product code: Code MRZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2007-05-22
Decision date: 2007-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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