CODMAN FLEXIBLE ENDOSCOPE

Endoscope, Flexible

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Flexible Endoscope.

Pre-market Notification Details

Device IDK871978
510k NumberK871978
Device Name:CODMAN FLEXIBLE ENDOSCOPE
ClassificationEndoscope, Flexible
Applicant Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph,  MA  02368 -1794
ContactThomas J Courage
CorrespondentThomas J Courage
Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph,  MA  02368 -1794
Product CodeGCQ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-22
Decision Date1987-08-25

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