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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 K920218
Device Name ESOPHAGEAL Z-STENT
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD. &
5951 GRASSY CREEK BLVD.
WINSTON-SALEM,  NC  27105
Applicant Contact RICHARD MARSHALL
Correspondent
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD. &
5951 GRASSY CREEK BLVD.
WINSTON-SALEM,  NC  27105
Correspondent Contact RICHARD MARSHALL
Regulation Number878.3610
Classification Product Code
ESW  
Date Received01/16/1992
Decision Date 02/09/1994
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
Recalls CDRH Recalls
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