Device Classification Name |
Bag, Urine Collection, Leg, For External Use, Sterile
|
510(k) Number |
K772402 |
Device Name |
QUADRIPLEGIC URINARY DRAINAGE VALVE |
Applicant |
FRED SAMMONS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
FRED SAMMONS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 12/27/1977 |
Decision Date | 01/26/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|