KARL STORZ MAGNIFYING ARTHROSOCPES

Arthroscope

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 Magnifying Arthrosocpes.

Pre-market Notification Details

Device IDK961228
510k NumberK961228
Device Name:KARL STORZ MAGNIFYING ARTHROSOCPES
ClassificationArthroscope
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactMarika Anderson
CorrespondentMarika Anderson
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-29
Decision Date1996-10-10
Summary:summary

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