The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4.
Device ID | K100378 |
510k Number | K100378 |
Device Name: | 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 |
Classification | Light, Ultraviolet, Dermatological |
Applicant | DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
Contact | Michele Thiel |
Correspondent | Michele Thiel 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 | 2010-02-16 |
Decision Date | 2010-04-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B280807OS0400X6A10 | K100378 | 000 |
B280806OS0004CX50 | K100378 | 000 |
B280807OS0400CX50 | K100378 | 000 |
B2809807OS0400X6A1 | K100378 | 000 |
B2809807OS0400X6 | K100378 | 000 |
B2809807OS0400X5A1 | K100378 | 000 |
B2809807OS0400X5 | K100378 | 000 |
B2809807OS0400T6A1 | K100378 | 000 |
B2809807OS0400T6 | K100378 | 000 |
B2809807OS0004X6 | K100378 | 000 |
B2809807OS0004X5 | K100378 | 000 |
B2809807OS0004T6 | K100378 | 000 |
B2809807OS0004T5 | K100378 | 000 |
B2809806OS0004X6 | K100378 | 000 |
B280807OS0004CX5BL0 | K100378 | 000 |
B280806OS0004CX60 | K100378 | 000 |
B280807OS0400X60 | K100378 | 000 |
B280807OS0400T6SD0 | K100378 | 000 |
B280807OS0400T6A10 | K100378 | 000 |
B280807OS0400T60 | K100378 | 000 |
B280807OS0004X6BL0 | K100378 | 000 |
B280807OS0004X60 | K100378 | 000 |
B280807OS0004T6BL0 | K100378 | 000 |
B280807OS0004T60 | K100378 | 000 |
B280806OS0004X60 | K100378 | 000 |
B280806OS0004T60 | K100378 | 000 |
B280807OS0004CX6BL04 | K100378 | 000 |
B280807OS0004CX60 | K100378 | 000 |
B280807OS0004CX50 | K100378 | 000 |
B2809806OS0004T6 | K100378 | 000 |