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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 K941728
Device Name MONOPOLAR COAGULATING POLYPECTOMY SNARE
Applicant
Endoscopic Innovations, Inc.
Morris Medical Center
Montana At First St.
Morris,  MN  56267
Applicant Contact JOHN L ZENK
Correspondent
Endoscopic Innovations, Inc.
Morris Medical Center
Montana At First St.
Morris,  MN  56267
Correspondent Contact JOHN L ZENK
Regulation Number876.4300
Classification Product Code
KNS  
Date Received04/07/1994
Decision Date 06/27/1994
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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