Device Classification Name |
Catheter, Urethral
|
510(k) Number |
K926369 |
Device Name |
WALTHER CATHETERS, MALE, FEMALE |
Applicant |
THOMASVILLE MEDICAL ASSOC. |
935 COBBLESTONE COURT |
ALPHARETTA,
GA
30201
|
|
Applicant Contact |
THOMAS J ZINNANTI |
Correspondent |
THOMASVILLE MEDICAL ASSOC. |
935 COBBLESTONE COURT |
ALPHARETTA,
GA
30201
|
|
Correspondent Contact |
THOMAS J ZINNANTI |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 12/22/1992 |
Decision Date | 05/21/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|