Device Classification Name |
Biopsy Needle
|
510(k) Number |
K951421 |
Device Name |
GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES |
Applicant |
GLOBAL MEDICAL PRODUCTS, LTD. |
2230 NURSERY RD. |
UNIT D41 |
CLEARWATER,
FL
34624
|
|
Applicant Contact |
DONALD RYAN |
Correspondent |
GLOBAL MEDICAL PRODUCTS, LTD. |
2230 NURSERY RD. |
UNIT D41 |
CLEARWATER,
FL
34624
|
|
Correspondent Contact |
DONALD RYAN |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 03/28/1995 |
Decision Date | 11/16/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|