Device Classification Name |
Marker, Skin
|
510(k) Number |
K042555 |
Device Name |
SURGICHIP TAG SURGICAL MARKER |
Applicant |
SURGICHIP, INC. |
4398 HICKORY DRIVE |
PALM GARDENS,
FL
33418
|
|
Applicant Contact |
BRUCE WAXMAN |
Correspondent |
SURGICHIP, INC. |
4398 HICKORY DRIVE |
PALM GARDENS,
FL
33418
|
|
Correspondent Contact |
BRUCE WAXMAN |
Regulation Number | 878.4660
|
Classification Product Code |
|
Date Received | 09/20/2004 |
Decision Date | 11/09/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|