REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600

Tubes, Gastrointestinal (and Accessories)

SUPERIOR HEALTHCARE GROUP, INC.

The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for Replacement Silicone Gastrostomy Tube Kit #87600.

Pre-market Notification Details

Device IDK880201
510k NumberK880201
Device Name:REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600
ClassificationTubes, Gastrointestinal (and Accessories)
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 CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-15
Decision Date1988-04-14

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