MODIFICATION TO SYSTEM 83 PLUS— 510(k) K983017

Clearance details

Applicant

Custom Ultrasonics

Product code

Code NVE

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

1998-08-28

Decision date

1998-09-22

Decision

Substantially Equivalent

Clearance type

Special

Location

Ivyland, PA, US

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• Z-0426-2014 — Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.Class II·Terminated·Custom Ultrasonics, Inc.·20130312

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983017.