Device Classification Name |
guide, surgical, instrument
|
510(k) Number |
K871503 |
Device Name |
BIOPSY NEEDLE GUIDE KIT, STERILE |
Applicant |
AMEDIC USA |
3702 EAST ROESER RD, STE |
27,P.O.B.62404 |
PHOENIX,
AZ
85040 -3969
|
|
Applicant Contact |
JACK A MOORE |
Correspondent |
AMEDIC USA |
3702 EAST ROESER RD, STE |
27,P.O.B.62404 |
PHOENIX,
AZ
85040 -3969
|
|
Correspondent Contact |
JACK A MOORE |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 04/17/1987 |
Decision Date | 07/10/1987 |
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
|
|
|