Device Classification Name |
needle, biopsy, cardiovascular
|
510(k) Number |
K933364 |
Device Name |
PROMED BIOPSY NEEDLE |
Applicant |
VLV ASSOCIATES, INC. |
30C RIDGEDALE AVE. |
EAST HANOVER,
NJ
07936
|
|
Applicant Contact |
VINCENT L VAILLANCOURT |
Correspondent |
VLV ASSOCIATES, INC. |
30C RIDGEDALE AVE. |
EAST HANOVER,
NJ
07936
|
|
Correspondent Contact |
VINCENT L VAILLANCOURT |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 07/09/1993 |
Decision Date | 02/15/1994 |
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
|
|
|