KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY

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 Multidrive Ii Mini Shaver For Arthroscopy.

Pre-market Notification Details

Device IDK970055
510k NumberK970055
Device Name:KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY
ClassificationArthroscope
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactRenate A Maclaren, Ph.d.
CorrespondentRenate A Maclaren, Ph.d.
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 Received1997-01-07
Decision Date1997-03-05
Summary:summary

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