The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for Dermapal With Digital Timer.
Device ID | K073587 |
510k Number | K073587 |
Device Name: | DERMAPAL WITH DIGITAL TIMER |
Classification | Light, Ultraviolet, Dermatological |
Applicant | DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
Contact | Tara Mansur |
Correspondent | Tara Mansur DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. 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 | 2007-12-20 |
Decision Date | 2008-01-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B280935DPNBDT600 | K073587 | 000 |
B280935DPBDT600 | K073587 | 000 |
B280935DPADT600 | K073587 | 000 |