UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA,— 510(k) K800518

Name: FDA 510(k) clearance K800518
Creator: U.S. Food and Drug Administration
Published: 1980-03-20

Substantially Equivalent

Kopharm, Inc.

FDA 510(k) clearance K800518 for UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA,, Substantially Equivalent on 1980-03-20. Applicant: Kopharm, Inc.. Device class: 2.

Clearance details

Applicant: Kopharm, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1980-03-05
Decision date: 1980-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.