Device Classification Name |
tray, catheterization, sterile urethral, with or without catheter (kit)
|
510(k) Number |
K901185 |
Device Name |
FOLEY CATHETER INSERTION TRAY (10CC) |
Applicant |
ORION LIFE SYSTEMS, INC. |
124 MESSNER DR. |
WHEELING,
IL
60090
|
|
Applicant Contact |
JOHN L LAEMMAR |
Correspondent |
ORION LIFE SYSTEMS, INC. |
124 MESSNER DR. |
WHEELING,
IL
60090
|
|
Correspondent Contact |
JOHN L LAEMMAR |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 03/13/1990 |
Decision Date | 07/20/1990 |
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
|
Recalls |
CDRH Recalls
|
|
|