Device Classification Name |
Instrument, Biopsy
|
510(k) Number |
K001132 |
Device Name |
BONE BIOPSY NEEDLE |
Applicant |
PROMEX, INC. |
3049 HUDSON ST. |
FRANKLIN,
IN
46131
|
|
Applicant Contact |
JOSEPH L MARK |
Correspondent |
PROMEX, INC. |
3049 HUDSON ST. |
FRANKLIN,
IN
46131
|
|
Correspondent Contact |
JOSEPH L MARK |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 04/10/2000 |
Decision Date | 05/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|