Device Classification Name |
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
|
510(k) Number |
K951479 |
Device Name |
CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE |
Applicant |
TRINITY LABORATORIES, INC. |
201 KILEY DR. |
P.O. BOX 1818 |
SALISBURY,
MD
21802
|
|
Applicant Contact |
B ASUMALLIK |
Correspondent |
TRINITY LABORATORIES, INC. |
201 KILEY DR. |
P.O. BOX 1818 |
SALISBURY,
MD
21802
|
|
Correspondent Contact |
B ASUMALLIK |
Regulation Number | 876.5130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/30/1995 |
Decision Date | 06/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|