Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K853846 |
Device Name |
SUN TANNING BED |
Applicant |
TAN AMERICA MFG. |
P. O. BOX 368 |
1147-C KCK WAY |
CEDAR HILL,
TX
75104
|
|
Applicant Contact |
JAMES DILLARD |
Correspondent |
TAN AMERICA MFG. |
P. O. BOX 368 |
1147-C KCK WAY |
CEDAR HILL,
TX
75104
|
|
Correspondent Contact |
JAMES DILLARD |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 09/16/1985 |
Decision Date | 10/29/1985 |
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
|