KSEA CALCUSPLIT

Lithotriptor, Electro-hydraulic

KARL STORZ ENDOSCOPY

The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Ksea Calcusplit.

Pre-market Notification Details

Device IDK992114
510k NumberK992114
Device Name:KSEA CALCUSPLIT
ClassificationLithotriptor, Electro-hydraulic
Applicant KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactKevin A Kennan
CorrespondentKevin A Kennan
KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeFFK  
CFR Regulation Number876.4480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-22
Decision Date1999-08-18
Summary:summary

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