Device Classification Name |
biopsy needle
|
510(k) Number |
K934256 |
Device Name |
GLOBAL MEDICAL CUTTING BIOPSY NEEDLE |
Applicant |
GLOBAL MEDICAL PRODS, INC. |
WICKHAMS CAY 1 |
P.O. BOX 362 |
ROAD TOWN, TORTOLA,
VG
|
|
Applicant Contact |
PETER CLARK |
Correspondent |
GLOBAL MEDICAL PRODS, INC. |
WICKHAMS CAY 1 |
P.O. BOX 362 |
ROAD TOWN, TORTOLA,
VG
|
|
Correspondent Contact |
PETER CLARK |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 08/31/1993 |
Decision Date | 03/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|