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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insufflator, carbon-dioxide, uterotubal (and accessories)
510(k) Number K862310
Device Name CABOT MEDICAL VARIABLE FLOW INSUFFLATOR
Applicant
CABOT MEDICAL CORP.
2021 CABOT BOULEVARD WEST
LANGHORNE,  PA  19047
Applicant Contact LOUIS A ANGELUCCI
Correspondent
CABOT MEDICAL CORP.
2021 CABOT BOULEVARD WEST
LANGHORNE,  PA  19047
Correspondent Contact LOUIS A ANGELUCCI
Regulation Number884.1300
Classification Product Code
HES  
Date Received06/17/1986
Decision Date 08/12/1986
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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