KSEA ENDOSCOPE HOLDER

Endoscope Holder

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 Endoscope Holder.

Pre-market Notification Details

Device IDK990334
510k NumberK990334
Device Name:KSEA ENDOSCOPE HOLDER
ClassificationEndoscope Holder
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactKevin A Kennan
CorrespondentKevin A Kennan
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeOCV  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-03
Decision Date1999-03-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551410912 K990334 000
04048551422335 K990334 000
04048551422328 K990334 000
04048551255902 K990334 000
04048551107539 K990334 000
04048551405109 K990334 000
04048551251669 K990334 000
04048551193679 K990334 000

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