Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K860198 |
Device Name |
MODEL 7500/000 KETTLER HOLIDAY SOLAR SUN TANNING |
Applicant |
MOTTEK INTL. CORP. |
7402 E CAMELBACK RD STE A |
SCOTTSDALE,
AZ
85251
|
|
Applicant Contact |
EDWARD SHAINER |
Correspondent |
MOTTEK INTL. CORP. |
7402 E CAMELBACK RD STE A |
SCOTTSDALE,
AZ
85251
|
|
Correspondent Contact |
EDWARD SHAINER |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 01/22/1986 |
Decision Date | 02/18/1986 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|