Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K954752 |
Device Name |
PEDIATRIC EUROPHYLIC FOLEY CATHETER |
Applicant |
REGULATORY & MARKETING SERVICES, INC. |
1247 FLORIDA AVE. |
PALM HARBOR,
FL
34682
|
|
Applicant Contact |
PATRICK J LAMB |
Correspondent |
REGULATORY & MARKETING SERVICES, INC. |
1247 FLORIDA AVE. |
PALM HARBOR,
FL
34682
|
|
Correspondent Contact |
PATRICK J LAMB |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 10/16/1995 |
Decision Date | 10/30/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|