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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K812213
Device Name AUTOMATED ELECTROCAUTERY SYSTEM
Applicant
UNIVERSITY OF WASHINGTON
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
UNIVERSITY OF WASHINGTON
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.4300
Classification Product Code
KNS  
Date Received08/05/1981
Decision Date 11/05/1981
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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