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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K880763
Device Name NEZHAT IRRIGATION PUMP SYSTEM
Applicant
CABOT MEDICAL CORP.
2021 CABOT BOULEVARD WEST
LANGHORNE,  PA  19047
Applicant Contact TODD POLK
Correspondent
CABOT MEDICAL CORP.
2021 CABOT BOULEVARD WEST
LANGHORNE,  PA  19047
Correspondent Contact TODD POLK
Regulation Number884.1720
Classification Product Code
HET  
Date Received02/25/1988
Decision Date 05/24/1988
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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