The following data is part of a premarket notification filed by Medtek Lighting Corp with the FDA for Mobile Versa Light.
Device ID | K111049 |
510k Number | K111049 |
Device Name: | MOBILE VERSA LIGHT |
Classification | Light, Ultraviolet, Dermatological |
Applicant | MEDTEK LIGHTING CORP 1131 ANTHEM VIEW LANE Knoxville, TN 37922 |
Contact | Robert Wagner |
Correspondent | Robert Wagner MEDTEK LIGHTING CORP 1131 ANTHEM VIEW LANE Knoxville, TN 37922 |
Product Code | FTC |
CFR Regulation Number | 878.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-15 |
Decision Date | 2012-05-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B343VL1400 | K111049 | 000 |
B343ML600 | K111049 | 000 |