Device Classification Name |
Guide, Surgical, Instrument
|
510(k) Number |
K852402 |
Device Name |
NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER |
Applicant |
NORTH AMERICAN INSTRUMENT CORP. |
HUDSON FALLS,
NY
12839
|
|
Applicant Contact |
PHILIP H MORSE |
Correspondent |
NORTH AMERICAN INSTRUMENT CORP. |
HUDSON FALLS,
NY
12839
|
|
Correspondent Contact |
PHILIP H MORSE |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 06/06/1985 |
Decision Date | 07/11/1985 |
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
|