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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coagulator-cutter, endoscopic, unipolar (and accessories)
510(k) Number K871960
Device Name ELECTRO-GYNE ELECTROSURGICAL GENERATOR
Applicant
CABOT MEDICAL CORP.
2021 CABOT BOULEVARD WEST
LANGHORNE,  PA  19047
Applicant Contact JOHN E MORDOCK
Correspondent
CABOT MEDICAL CORP.
2021 CABOT BOULEVARD WEST
LANGHORNE,  PA  19047
Correspondent Contact JOHN E MORDOCK
Regulation Number884.4160
Classification Product Code
KNF  
Date Received05/20/1987
Decision Date 07/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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