KSEA MODEL 203200 20 UNIMAT

Laparoscope, Gynecologic (and Accessories)

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 203200 20 Unimat.

Pre-market Notification Details

Device IDK953190
510k NumberK953190
Device Name:KSEA MODEL 203200 20 UNIMAT
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactRenate A Maclaren
CorrespondentRenate A Maclaren
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-10
Decision Date1995-10-05

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