Device Classification Name |
Catheter, Malecot
|
510(k) Number |
K954116 |
Device Name |
SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP |
Applicant |
TECHNICAL PRODUCTS, INC. |
2416 PARK CENTRAL BLVD. |
DECATUR,
GA
30035
|
|
Applicant Contact |
NORBERT D THOMPSON |
Correspondent |
TECHNICAL PRODUCTS, INC. |
2416 PARK CENTRAL BLVD. |
DECATUR,
GA
30035
|
|
Correspondent Contact |
NORBERT D THOMPSON |
Regulation Number | 876.5090
|
Classification Product Code |
|
Date Received | 07/20/1995 |
Decision Date | 11/06/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|