Device Classification Name |
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
|
510(k) Number |
K960566 |
Device Name |
NHMC FOLEY CATHETERIZATION TRAY |
Applicant |
NATIONAL HEALTHCARE MFG. CORP. |
251 SAULTEAUX CRESCENT |
WINNIPEG, MANITOBA,
CA
R3J 3C7
|
|
Applicant Contact |
BOB JACKSON |
Correspondent |
NATIONAL HEALTHCARE MFG. CORP. |
251 SAULTEAUX CRESCENT |
WINNIPEG, MANITOBA,
CA
R3J 3C7
|
|
Correspondent Contact |
BOB JACKSON |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 02/09/1996 |
Decision Date | 02/29/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|