SPOT ENDOSCOPIC MARKER

Marker, Colon

CHEK-MED SYSTEMS

The following data is part of a premarket notification filed by Chek-med Systems with the FDA for Spot Endoscopic Marker.

Pre-market Notification Details

Device IDK993951
510k NumberK993951
Device Name:SPOT ENDOSCOPIC MARKER
ClassificationMarker, Colon
Applicant CHEK-MED SYSTEMS 11 PHELPS WAY P.O. BOX 289 Willington,  CT  06279
ContactRob Whalen
CorrespondentRob Whalen
CHEK-MED SYSTEMS 11 PHELPS WAY P.O. BOX 289 Willington,  CT  06279
Product CodeNBG  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-22
Decision Date2000-02-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.