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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, esophageal
510(k) Number K851955
Device Name SAVARY-GILLIARD DILATOR
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Applicant Contact JON WILSON
Correspondent
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Correspondent Contact JON WILSON
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received05/03/1985
Decision Date 07/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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