NO. 86500 - ENDOSCOPIC JET WASHER

Endoscopic Irrigation/suction System

SUPERIOR HEALTHCARE GROUP, INC.

The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for No. 86500 - Endoscopic Jet Washer.

Pre-market Notification Details

Device IDK892426
510k NumberK892426
Device Name:NO. 86500 - ENDOSCOPIC JET WASHER
ClassificationEndoscopic Irrigation/suction System
Applicant SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland,  RI  02864
ContactPaul Bernard
CorrespondentPaul Bernard
SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland,  RI  02864
Product CodeOCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-10
Decision Date1989-06-22

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