NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.

Catheters, Suction, Tracheobronchial

SUPERIOR HEALTHCARE GROUP, INC.

The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for No. 34100 - 8 Fr & No. 34400 - 14 Fr Closed Trach..

Pre-market Notification Details

Device IDK896321
510k NumberK896321
Device Name:NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.
ClassificationCatheters, Suction, Tracheobronchial
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 CodeBSY  
CFR Regulation Number868.6810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-01
Decision Date1989-11-13

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