The following data is part of a premarket notification filed by Daavlin Co. with the FDA for Spectra 724.
Device ID | K854498 |
510k Number | K854498 |
Device Name: | SPECTRA 724 |
Classification | Light, Ultraviolet, Dermatological |
Applicant | DAAVLIN CO. P.O. BOX 626 205 W. BEMENT STREET Bryan, OH 43506 |
Contact | David W Swanson |
Correspondent | David W Swanson DAAVLIN CO. P.O. BOX 626 205 W. BEMENT STREET Bryan, OH 43506 |
Product Code | FTC |
CFR Regulation Number | 878.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-12 |
Decision Date | 1985-11-25 |