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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, electrosurgical, active, urological
510(k) Number K943879
Device Name RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP
Applicant
AMERICAN UROLOGICALS, INC.
P.O. BOX 591137
SAN FRANCISCO,  CA  94159
Applicant Contact PERINCHERY NARAYAN
Correspondent
AMERICAN UROLOGICALS, INC.
P.O. BOX 591137
SAN FRANCISCO,  CA  94159
Correspondent Contact PERINCHERY NARAYAN
Regulation Number876.4300
Classification Product Code
FAS  
Date Received08/09/1994
Decision Date 02/07/1995
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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