Device Classification Name |
Urinary Drainage Collection Kit, For Indwelling Catheter
|
510(k) Number |
K883610 |
Device Name |
LAKE FOLEY CATHETERIZATION TRAY |
Applicant |
LAKE MEDICAL PRODUCTS, INC. |
1145 MOOG DR. |
ST. LOUIS,
MO
63146
|
|
Applicant Contact |
ELI SCHACHET |
Correspondent |
LAKE MEDICAL PRODUCTS, INC. |
1145 MOOG DR. |
ST. LOUIS,
MO
63146
|
|
Correspondent Contact |
ELI SCHACHET |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 08/22/1988 |
Decision Date | 10/12/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|