DISPO-URETTE— 510(k) K860796

Substantially Equivalent

Roland J. Zwick, Inc.

FDA 510(k) clearance K860796 for DISPO-URETTE, Substantially Equivalent on 1986-04-08. Applicant: Roland J. Zwick, Inc.. Device class: 2.

Clearance details

Applicant: Roland J. Zwick, Inc.
Product code: Code PCF
Device class: Class 2
Regulation: 21 CFR 884.1050
Advisory panel: Obstetrics/Gynecology
Date received: 1986-03-04
Decision date: 1986-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, 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.