NEOMED URINARY CATHETER


Device Classification Name

catheter, straight

510(k) Number K072997
Device Name NEOMED URINARY CATHETER
Applicant
NEOMED, INC.
717 lakeglen dr.
suwanee, 
GA 
30024

Applicant Contact penny northcutt
Correspondent
NEOMED, INC.
717 lakeglen dr.
suwanee, 
GA 
30024

Correspodent Contact penny northcutt
Regulation Number 876.5130
Classification Product Code
EZD  
Subsequent Product Code
GBM  
Date Received 10/24/2007
Decision Date 12/19/2007
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