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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K923119
Device Name WALLSTENT ESOPHAGEAL PROTHESIS
Applicant
Schneider U.S. Stent Div.
5905 Nathan Ln.
Plymouth,  MN  55442
Applicant Contact RUSSELL W OLSON
Correspondent
Schneider U.S. Stent Div.
5905 Nathan Ln.
Plymouth,  MN  55442
Correspondent Contact RUSSELL W OLSON
Regulation Number878.3610
Classification Product Code
ESW  
Date Received06/26/1992
Decision Date 09/01/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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