CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS

Port & Catheter, Implanted, Subcutaneous, Intravascular

TRI-STATE HOSPITAL SUPPLY CORP.

The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Centlurion Disp Steri Dental/hygiene Pack/trays.

Pre-market Notification Details

Device IDK931748
510k NumberK931748
Device Name:CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. P.O. BOX 170 Howell,  MI  48843
ContactGeorge J Pluta
CorrespondentGeorge J Pluta
TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. P.O. BOX 170 Howell,  MI  48843
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-08
Decision Date1994-02-25

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