| 510(k) Number |
K827690 |
| Device Name |
SPECTRA MINI, ULTRAVIOLET EMITTER FOR DERMATOLOGICAL USE |
| Applicant |
| Daavlin Co. |
| P O Box 626 |
|
Bryan,
OH
43506
|
|
| Correspondent |
| Daavlin Co. |
| P O Box 626 |
|
Bryan,
OH
43506
|
|
| Date Received | 09/20/1982 |
| Decision Date | 10/05/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|