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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K932626
Device Name CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB
Applicant
CABOT MEDICAL CORP.
2021 CABOT BOULEVARD WEST
LANGHORNE,  PA  19047
Applicant Contact TODD J POLK
Correspondent
CABOT MEDICAL CORP.
2021 CABOT BOULEVARD WEST
LANGHORNE,  PA  19047
Correspondent Contact TODD J POLK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/01/1993
Decision Date 06/08/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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