Device Classification Name |
catheter, upper urinary tract
|
510(k) Number |
K925790 |
Device Name |
EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S |
Applicant |
DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. |
POWELL,
TN
37849
|
|
Applicant Contact |
DEBRA F MANNING |
Correspondent |
DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. |
POWELL,
TN
37849
|
|
Correspondent Contact |
DEBRA F MANNING |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 11/16/1992 |
Decision Date | 05/17/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|