KARL STORZ 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 Karl Storz Electronic Laparoflator.

Pre-market Notification Details

Device IDK934043
510k NumberK934043
Device Name:KARL STORZ ELECTRONIC LAPAROFLATOR
ClassificationInsufflator, Laparoscopic
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City,  CA  90232 -3578
ContactRobert R Giorgini
CorrespondentRobert R Giorgini
KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City,  CA  90232 -3578
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-19
Decision Date1994-05-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.