5 STAR MEDICAL ENDOSCOPE

Mini Endoscope, Gastroenterology-urology

FIVE STAR MEDICAL, INC.

The following data is part of a premarket notification filed by Five Star Medical, Inc. with the FDA for 5 Star Medical Endoscope.

Pre-market Notification Details

Device IDK963354
510k NumberK963354
Device Name:5 STAR MEDICAL ENDOSCOPE
ClassificationMini Endoscope, Gastroenterology-urology
Applicant FIVE STAR MEDICAL, INC. 4767 WREN COURT Charlottesville,  VA  22911
ContactBeverly J Stewart
CorrespondentBeverly J Stewart
FIVE STAR MEDICAL, INC. 4767 WREN COURT Charlottesville,  VA  22911
Product CodeODF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-26
Decision Date1997-09-08
Summary:summary

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