KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE

Choledochoscope And Accessories, Flexible/rigid

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea 15.5 Fr. Flexible Choledocho-fiberscope.

Pre-market Notification Details

Device IDK971977
510k NumberK971977
Device Name:KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
ClassificationCholedochoscope And Accessories, Flexible/rigid
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactMarlena Allen Piercy
CorrespondentMarlena Allen Piercy
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeFBN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-29
Decision Date1997-08-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551050651 K971977 000

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