Device Classification Name |
Guide, Needle, Surgical
|
510(k) Number |
K924270 |
Device Name |
BREAST LESION LOCALIZATION NEEDLE |
Applicant |
CORE MEDICAL, INC. |
795 DAVIDSON DRIVE NORTH WEST |
CONCORD,
NC
28025
|
|
Applicant Contact |
DON RYAN |
Correspondent |
CORE MEDICAL, INC. |
795 DAVIDSON DRIVE NORTH WEST |
CONCORD,
NC
28025
|
|
Correspondent Contact |
DON RYAN |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 08/24/1992 |
Decision Date | 09/23/1992 |
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
|
|
|