KSEA DION-GRACIA SET

Clamp, Vascular

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 Dion-gracia Set.

Pre-market Notification Details

Device IDK010785
510k NumberK010785
Device Name:KSEA DION-GRACIA SET
ClassificationClamp, Vascular
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactJames A Lee
CorrespondentJames A Lee
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-15
Decision Date2001-08-21

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