Device Classification Name |
Marker, Skin
|
510(k) Number |
K912730 |
Device Name |
ROCKET SURGICAL SKIN MARKING PEN |
Applicant |
WEST TEXAS LIGHTHOUSE FOR THE BLIND |
2001 AUSTIN ST. |
SAN ANGELO,
TX
76903
|
|
Applicant Contact |
RONALD J BEARD |
Correspondent |
WEST TEXAS LIGHTHOUSE FOR THE BLIND |
2001 AUSTIN ST. |
SAN ANGELO,
TX
76903
|
|
Correspondent Contact |
RONALD J BEARD |
Regulation Number | 878.4660
|
Classification Product Code |
|
Date Received | 06/20/1991 |
Decision Date | 11/07/1991 |
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
|