PBN DRAINAGE CATHETER GUIDEWIRES


Device Classification Name

accessories, catheter, g-u

510(k) Number K991097
Device Name PBN DRAINAGE CATHETER GUIDEWIRES
Applicant
MEDICAL DEVICE TECHNOLOGIES, INC.
3600 sw 47th avenue
gainesville, 
FL 
32608

Applicant Contact karl swartz
Correspondent
MEDICAL DEVICE TECHNOLOGIES, INC.
3600 sw 47th avenue
gainesville, 
FL 
32608

Correspodent Contact karl swartz
Regulation Number 876.5130
Classification Product Code
KNY  
Date Received 04/01/1999
Decision Date 04/23/1999
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