KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR

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 Model 26012ch Electronic Laparoflator.

Pre-market Notification Details

Device IDK951961
510k NumberK951961
Device Name:KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR
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 Received1995-04-26
Decision Date1995-08-01

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