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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 K873517
Device Name DEKNATEL THORACIC CATHETER
Applicant
Deknatel, Inc.
2300 Marcus Ave.
Lake Success,  NY  11042
Applicant Contact BETTY OROFINO
Correspondent
Deknatel, Inc.
2300 Marcus Ave.
Lake Success,  NY  11042
Correspondent Contact BETTY OROFINO
Regulation Number880.6740
Classification Product Code
JOL  
Date Received09/01/1987
Decision Date 11/02/1987
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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