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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K830483
Device Name COONS SOFT STENT
Applicant
MEDI-TECH, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDI-TECH, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/15/1983
Decision Date 03/09/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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