Cleared Traditional

PERCUPUMP II

K932055 · E-Z-Em, Inc. · Radiology
Mar 1995
Decision
692d
Days
Class 2
Risk

About This 510(k) Submission

K932055 is an FDA 510(k) clearance for the PERCUPUMP II, a Pump, Infusion Or Syringe, Extra-luminal (Class II — Special Controls, product code FIH), submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on March 21, 1995, 692 days after receiving the submission on April 28, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K932055 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1993
Decision Date March 21, 1995
Days to Decision 692 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code FIH — Pump, Infusion Or Syringe, Extra-luminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820