Device Classification Name |
Needle, Biopsy, Cardiovascular
|
510(k) Number |
K853312 |
Device Name |
ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES |
Applicant |
ARGON MEDICAL CORP. |
1445 FLAT CREEK RD. |
P.O. BOX 1970 |
ATHENS,
TX
75751
|
|
Applicant Contact |
RUSSELL JONES |
Correspondent |
ARGON MEDICAL CORP. |
1445 FLAT CREEK RD. |
P.O. BOX 1970 |
ATHENS,
TX
75751
|
|
Correspondent Contact |
RUSSELL JONES |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 08/07/1985 |
Decision Date | 09/12/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|