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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic cytology brush
510(k) Number K923200
Device Name AMCATH DISPOSABLE CYTOLOGY BRUSH
Applicant
INTL. MEDICAL, INC.
175 CONNECTICUT MILLS AVE.
DANIELSON,  CT  06239
Applicant Contact PETER H WETTERMANN
Correspondent
INTL. MEDICAL, INC.
175 CONNECTICUT MILLS AVE.
DANIELSON,  CT  06239
Correspondent Contact PETER H WETTERMANN
Regulation Number876.1500
Classification Product Code
FDX  
Date Received06/30/1992
Decision Date 12/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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