Device Classification Name |
Marker, Skin
|
510(k) Number |
K864371 |
Device Name |
SURGICAL SKIN MARKER |
Applicant |
MYOCURE, INC. |
1736 FLOWER ST. |
GLENDALE,
CA
91201
|
|
Applicant Contact |
C.JENSEN, M.D. |
Correspondent |
MYOCURE, INC. |
1736 FLOWER ST. |
GLENDALE,
CA
91201
|
|
Correspondent Contact |
C.JENSEN, M.D. |
Regulation Number | 878.4660
|
Classification Product Code |
|
Date Received | 11/05/1986 |
Decision Date | 11/17/1986 |
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
|
|
|