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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic injection needle, gastroenterology-urology
510(k) Number K030451
Device Name CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE
Applicant
CARBON MEDICAL TECHNOLOGIES, INC.
1290 HAMMOND RD.
ST. PAUL,  MN  55110
Applicant Contact ROBERT W JOHNSON
Correspondent
CARBON MEDICAL TECHNOLOGIES, INC.
1290 HAMMOND RD.
ST. PAUL,  MN  55110
Correspondent Contact ROBERT W JOHNSON
Regulation Number876.1500
Classification Product Code
FBK  
Date Received02/11/2003
Decision Date 04/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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