Device Classification Name |
Biopsy Needle
|
510(k) Number |
K954231 |
Device Name |
AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT |
Applicant |
PROMEX, INC. |
1125 BROOKSIDE AVE. |
SUITE G500 |
INDIANAPOLIS,
IN
46202
|
|
Applicant Contact |
JOSEPH L MARK |
Correspondent |
PROMEX, INC. |
1125 BROOKSIDE AVE. |
SUITE G500 |
INDIANAPOLIS,
IN
46202
|
|
Correspondent Contact |
JOSEPH L MARK |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 09/11/1995 |
Decision Date | 09/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|