CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE


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

Correspodent Contact robert w johnson
Regulation Number 876.1500
Classification Product Code
FBK  
Date Received 02/11/2003
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