Device Classification Name |
Needle, Aspiration And Injection, Reusable
|
510(k) Number |
K874928 |
Device Name |
WHOLEY (TM) BIOPSY DEVICE |
Applicant |
MEDRAD, INC. |
271 KAPPA DR. |
PITTSBURGH,
PA
15238 -2870
|
|
Applicant Contact |
RUEY C DEMPSEY |
Correspondent |
MEDRAD, INC. |
271 KAPPA DR. |
PITTSBURGH,
PA
15238 -2870
|
|
Correspondent Contact |
RUEY C DEMPSEY |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 12/02/1987 |
Decision Date | 12/30/1987 |
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
|