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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K963029
Device Name KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE
Applicant
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact MARIKA ANDERSON
Correspondent
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact MARIKA ANDERSON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/05/1996
Decision Date 11/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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