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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 K932015
Device Name TRI-MED INFLATABLE ESOPHAGEAL DILATOR
Applicant
Tri-Med Specialties, Inc.
P.O. Box 23306
Overland Park,  KS  66223
Applicant Contact LARRY SCOTT
Correspondent
Tri-Med Specialties, Inc.
P.O. Box 23306
Overland Park,  KS  66223
Correspondent Contact LARRY SCOTT
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received04/23/1993
Decision Date 02/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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