DENVER PERITONEO-VENUS SHUNT

Shunt, Peritoneal

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Denver Peritoneo-venus Shunt.

Pre-market Notification Details

Device IDK894756
510k NumberK894756
Device Name:DENVER PERITONEO-VENUS SHUNT
ClassificationShunt, Peritoneal
Applicant Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph,  MA  02368 -1794
ContactDonald A Lincoln
CorrespondentDonald A Lincoln
Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph,  MA  02368 -1794
Product CodeKPM  
CFR Regulation Number876.5955 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-27
Decision Date1989-09-29

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