PERCUPUMP II— 510(k) K932055

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K932055 for PERCUPUMP II, Substantially Equivalent on 1995-03-21. Applicant: E-Z-Em, Inc.. Device class: 2.

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code FIH
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1993-04-28
Decision date: 1995-03-21
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.