KSEA THERMOFLATOR (MODEL 26 4320 20)

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 Thermoflator (model 26 4320 20).

Pre-market Notification Details

Device IDK955073
510k NumberK955073
Device Name:KSEA THERMOFLATOR (MODEL 26 4320 20)
ClassificationInsufflator, Laparoscopic
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 CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-06
Decision Date1996-12-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048438003473 K955073 000

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