| 510(k) Number |
K852321 |
| Device Name |
SYLVANIA F8T5/PUVA & WALDMANN F15T8/PUVA |
| Applicant |
| Sylvania Lighting Products |
| 100 Endicott St. |
|
Danvers,
MA
01923
|
|
| Applicant Contact |
WARREN J FIELD |
| Correspondent |
| Sylvania Lighting Products |
| 100 Endicott St. |
|
Danvers,
MA
01923
|
|
| Correspondent Contact |
WARREN J FIELD |
| Date Received | 05/30/1985 |
| Decision Date | 07/11/1985 |
| Decision |
Substantially Equivalent - With Drug
(SESD) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|