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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 K944861
Device Name KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE
Applicant
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact JUDITH K MURPHY
Correspondent
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact JUDITH K MURPHY
Regulation Number874.4760
Classification Product Code
EOB  
Date Received10/03/1994
Decision Date 02/21/1995
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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