P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY

Tube, Gastro-enterostomy

APPLIED MEDICAL TECHNOLOGIES

The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for P.r.g. Percutaneous Replacement Gastrostomy.

Pre-market Notification Details

Device IDK900884
510k NumberK900884
Device Name:P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY
ClassificationTube, Gastro-enterostomy
Applicant APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence,  OH  44131
ContactPat Gilpin
CorrespondentPat Gilpin
APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence,  OH  44131
Product CodeKGC  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent - With Drug (SESD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-26
Decision Date1990-07-02

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