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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mediastinoscope, Surgical
510(k) Number K954910
Device Name KARL STORZ OPTICAL MEDIASTINOSCOPE
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact RENATE A MACLAREN
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Correspondent Contact RENATE A MACLAREN
Regulation Number874.4720
Classification Product Code
EWY  
Date Received10/25/1995
Decision Date 11/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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