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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocautery, Gynecologic (And Accessories)
510(k) Number K963852
Device Name KSEA THERMOCOAGULATOR (MODEL 265100 20)
Applicant
Karl Storz Endoscopy-America, Inc.
600 Corporate Pointe
Culver City,  CA  90230 -7600
Applicant Contact BETTY M JOHNSON
Correspondent
Karl Storz Endoscopy-America, Inc.
600 Corporate Pointe
Culver City,  CA  90230 -7600
Correspondent Contact BETTY M JOHNSON
Regulation Number884.4120
Classification Product Code
HGI  
Subsequent Product Code
HET  
Date Received09/25/1996
Decision Date 12/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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