Device Classification Name |
tray, surgical, instrument
|
510(k) Number |
K870417 |
Device Name |
RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY |
Applicant |
NORTH COAST MEDI-TEK |
8603 EAST AVE. |
MENTOR,
OH
44060
|
|
Applicant Contact |
THERESA SOKOLOWSKI |
Correspondent |
NORTH COAST MEDI-TEK |
8603 EAST AVE. |
MENTOR,
OH
44060
|
|
Correspondent Contact |
THERESA SOKOLOWSKI |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 02/03/1987 |
Decision Date | 03/05/1987 |
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
|