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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 K895402
Device Name ENDOCOAGULATOR 2001 KLI
Applicant
CABOT MEDICAL CORP.
2021 CABOT BOULEVARD WEST
LANGHORNE,  PA  19047
Applicant Contact CAROLYN DEJONGE
Correspondent
CABOT MEDICAL CORP.
2021 CABOT BOULEVARD WEST
LANGHORNE,  PA  19047
Correspondent Contact CAROLYN DEJONGE
Regulation Number884.4120
Classification Product Code
HGI  
Date Received09/07/1989
Decision Date 04/26/1990
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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