Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K827890 |
Device Name |
FOLDALITE UNIT |
Applicant |
NATIONAL BIOLOGICAL CORP. |
1532 ENTERPRISE PKWY. |
TWINSBURG,
OH
44087
|
|
Correspondent |
NATIONAL BIOLOGICAL CORP. |
1532 ENTERPRISE PKWY. |
TWINSBURG,
OH
44087
|
|
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 08/11/1982 |
Decision Date | 08/23/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|