Device Classification Name |
light, ultraviolet, dermatological
|
510(k) Number |
K070934 |
Device Name |
PANOSOL II TRU-BLU, MODEL UBL-417 |
Applicant |
NATIONAL BIOLOGICAL CORP. |
1532 ENTERPRISE PKWY. |
TWINSBURG,
OH
44087
|
|
Applicant Contact |
GEORGE KRINER |
Correspondent |
NATIONAL BIOLOGICAL CORP. |
1532 ENTERPRISE PKWY. |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
GEORGE KRINER |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 04/03/2007 |
Decision Date | 05/22/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|