KSEA N2O ENDOFLATOR

Insufflator, Laparoscopic

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 N2o Endoflator.

Pre-market Notification Details

Device IDK980134
510k NumberK980134
Device Name:KSEA N2O ENDOFLATOR
ClassificationInsufflator, Laparoscopic
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactKevin A Kennan
CorrespondentKevin A Kennan
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-15
Decision Date1998-04-15
Summary:summary

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