KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP

Insufflator, Hysteroscopic

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 Disposable Tubing Sets For The Hamou Endomat Pump.

Pre-market Notification Details

Device IDK950961
510k NumberK950961
Device Name:KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
ClassificationInsufflator, Hysteroscopic
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactBetty M Johnson
CorrespondentBetty M Johnson
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeHIG  
CFR Regulation Number884.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-02
Decision Date1995-05-25

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