Device Classification Name |
instrument, biopsy
|
510(k) Number |
K010400 |
Device Name |
VACUUM ASSISTED CORE BIOPSY DEVICE |
Applicant |
PROMEX, INC. |
3049 HUDSON ST. |
P.O. BOX 787 |
FRANKLIN,
IN
46131
|
|
Applicant Contact |
JOSEPH L MARK |
Correspondent |
PROMEX, INC. |
3049 HUDSON ST. |
P.O. BOX 787 |
FRANKLIN,
IN
46131
|
|
Correspondent Contact |
JOSEPH L MARK |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 02/12/2001 |
Decision Date | 07/24/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|