Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K990509 |
Device Name |
OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 |
Applicant |
IMPLEMED, INC. |
313 PLEASANT ST. |
WATERTOWN,
MA
02172
|
|
Applicant Contact |
ANTHONY L BLANK |
Correspondent |
IMPLEMED, INC. |
313 PLEASANT ST. |
WATERTOWN,
MA
02172
|
|
Correspondent Contact |
ANTHONY L BLANK |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 02/18/1999 |
Decision Date | 05/18/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|