RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR

Endoscopic Access Overtube, Gastroenterology-urology

COLOPLAST A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Re-trace Ureteral Access Sheath, 10/12 French, Length 35 And 45 Cm, Ureteral Access Sheath, 12/14 Ch-fr, Length 35cm, Ur.

Pre-market Notification Details

Device IDK123675
510k NumberK123675
Device Name:RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
ClassificationEndoscopic Access Overtube, Gastroenterology-urology
Applicant COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis,  MN  55411
ContactBrian Schmidt
CorrespondentBrian Schmidt
COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis,  MN  55411
Product CodeFED  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-30
Decision Date2013-03-01
Summary:summary

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