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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K915719
Device Name ANGEION ENDOSCOPIC VALVE SEAL
Applicant
Angeion Corp.
13000 Hwy. 55
Plymouth,  MN  55441
Applicant Contact STEVEN W HENTLEY
Correspondent
Angeion Corp.
13000 Hwy. 55
Plymouth,  MN  55441
Correspondent Contact STEVEN W HENTLEY
Regulation Number876.1500
Classification Product Code
ODC  
Date Received12/20/1991
Decision Date 02/18/1992
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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