Device Classification Name |
tray, catheterization, sterile urethral, with or without catheter (kit)
|
510(k) Number |
K910022 |
Device Name |
MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT |
Applicant |
MEDICAL MARKETING GROUP |
5335 DIVIDEND DR. |
DECATUR,
GA
30035
|
|
Applicant Contact |
TIMOTHY D GOLDEN |
Correspondent |
MEDICAL MARKETING GROUP |
5335 DIVIDEND DR. |
DECATUR,
GA
30035
|
|
Correspondent Contact |
TIMOTHY D GOLDEN |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 01/03/1991 |
Decision Date | 04/02/1991 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|