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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K941232
Device Name THORA-CATH
Applicant
Gesco Intl., Inc.
5714 Epsilon Dr.
San Antonio,  TX  78249
Applicant Contact CLYDE N BAKER
Correspondent
Gesco Intl., Inc.
5714 Epsilon Dr.
San Antonio,  TX  78249
Correspondent Contact CLYDE N BAKER
Regulation Number880.6740
Classification Product Code
JOL  
Date Received03/15/1994
Decision Date 05/11/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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