PERCU-SET(TM)— 510(k) K900021

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K900021 for PERCU-SET(TM), Substantially Equivalent on 1990-03-29. Applicant: E-Z-Em, Inc.. Device class: 1.

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code HIO
Device class: Class 1
Regulation: 21 CFR 884.1550
Advisory panel: Obstetrics/Gynecology
Date received: 1990-01-02
Decision date: 1990-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westbury, NY, 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.