Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K022104 |
Device Name |
DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ |
Applicant |
DAAVLIN DISTRIBUTING CO. |
205 WEST BEMENT ST. |
BRYAN,
OH
43506
|
|
Applicant Contact |
CHAD REYNOLDS |
Correspondent |
DAAVLIN DISTRIBUTING CO. |
205 WEST BEMENT ST. |
BRYAN,
OH
43506
|
|
Correspondent Contact |
CHAD REYNOLDS |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 06/28/2002 |
Decision Date | 09/10/2002 |
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
|
|
|