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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 K955041
Device Name INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM
Applicant
Instent, Inc.
6271 Bury Dr.
Eden Prairie,  MN  55346
Applicant Contact KARL GROTH
Correspondent
Instent, Inc.
6271 Bury Dr.
Eden Prairie,  MN  55346
Correspondent Contact KARL GROTH
Regulation Number878.3610
Classification Product Code
ESW  
Date Received11/03/1995
Decision Date 02/21/1996
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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