Device Classification Name |
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
|
510(k) Number |
K923538 |
Device Name |
MON-A-THERM FOLEY KIT |
Applicant |
MALLINCKRODT MEDICAL |
675 MCDONNELL BLVD. |
P.O. BOX 5840 |
ST. LOUIS,
MO
63134
|
|
Applicant Contact |
JEFFERY W BIGGERS |
Correspondent |
MALLINCKRODT MEDICAL |
675 MCDONNELL BLVD. |
P.O. BOX 5840 |
ST. LOUIS,
MO
63134
|
|
Correspondent Contact |
JEFFERY W BIGGERS |
Regulation Number | 876.5130 |
Classification Product Code |
|
Date Received | 07/16/1992 |
Decision Date | 05/27/1993 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|