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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 K924530
Device Name CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI
Applicant
Cabot Medical Corp.
2021 Cabot Blvd. W.
Langhorne,  PA  19047
Applicant Contact TODD J POLK
Correspondent
Cabot Medical Corp.
2021 Cabot Blvd. W.
Langhorne,  PA  19047
Correspondent Contact TODD J POLK
Regulation Number884.1720
Classification Product Code
HET  
Date Received09/08/1992
Decision Date 02/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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