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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 K903162
Device Name FLEXIBLE ENDOSCOPIC 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
Predetermined Change
Control Plan Authorized		 No
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