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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nasopharyngoscope (flexible or rigid)
510(k) Number K943816
Device Name TROCARS,CANNULAE, SHEATHS
Applicant
KARL STORZ ENDOSKOP GMBH
600 CORPORATE POINTE
CULVER CITY,  CA  90230
Applicant Contact MARIKA ANDERSON
Correspondent
KARL STORZ ENDOSKOP GMBH
600 CORPORATE POINTE
CULVER CITY,  CA  90230
Correspondent Contact MARIKA ANDERSON
Regulation Number874.4760
Classification Product Code
EOB  
Date Received08/05/1994
Decision Date 08/24/1994
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
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