UNI-SEM(TM)— 510(k) K910317

Substantially Equivalent

Unimar, Inc.

FDA 510(k) clearance K910317 for UNI-SEM(TM), Substantially Equivalent on 1991-05-01. Applicant: Unimar, Inc.. Device class: 2.

Clearance details

Applicant: Unimar, Inc.
Product code: Code MFD
Device class: Class 2
Regulation: 21 CFR 884.5250
Advisory panel: Obstetrics/Gynecology
Date received: 1991-01-24
Decision date: 1991-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilton, CT, US

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