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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 K820430
Device Name DIATHERMIC SNARES
Applicant
AMERICAN ENDOSCOPY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN ENDOSCOPY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.4300
Classification Product Code
KNS  
Subsequent Product Code
FDI  
Date Received02/17/1982
Decision Date 04/08/1982
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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