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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 K903156
Device Name CONTROL-TIP CYSTOSCOPIC ELECTRODES
Applicant
NORTH AMERICAN STERILIZATION & PACKAGING CO.
15 WHITE LAKE RD.
P.O. BOX 923
SPARTA,  NJ  07871
Applicant Contact HARRY SCHLAKMAN
Correspondent
NORTH AMERICAN STERILIZATION & PACKAGING CO.
15 WHITE LAKE RD.
P.O. BOX 923
SPARTA,  NJ  07871
Correspondent Contact HARRY SCHLAKMAN
Regulation Number876.4300
Classification Product Code
FAS  
Date Received07/18/1990
Decision Date 12/18/1990
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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