KSEA MONOPOLAR VAPORIZATION ELECTRODES

Hysteroscope (and Accessories)

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 Monopolar Vaporization Electrodes.

Pre-market Notification Details

Device IDK001740
510k NumberK001740
Device Name:KSEA MONOPOLAR VAPORIZATION ELECTRODES
ClassificationHysteroscope (and Accessories)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactKevin Kennan
CorrespondentKevin Kennan
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-08
Decision Date2000-08-22

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