Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K041212 |
Device Name |
HOUVA 3 PHOTOTHERAPY SYSTEM |
Applicant |
NATIONAL BIOLOGICAL CORP. |
1532 ENTERPRISE PKWY. |
TWINSBURG,
OH
44087
|
|
Applicant Contact |
LORETTA MOONEY |
Correspondent |
NATIONAL BIOLOGICAL CORP. |
1532 ENTERPRISE PKWY. |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
LORETTA MOONEY |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 05/10/2004 |
Decision Date | 06/09/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|