ENDOSCOPIC ELASTIC BAND LIGATOR

Ligator, Hemorrhoidal

SUPERIOR HEALTHCARE GROUP, INC.

The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for Endoscopic Elastic Band Ligator.

Pre-market Notification Details

Device IDK880648
510k NumberK880648
Device Name:ENDOSCOPIC ELASTIC BAND LIGATOR
ClassificationLigator, Hemorrhoidal
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 CodeFHN  
CFR Regulation Number876.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-17
Decision Date1988-04-06

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