FDA 510(k) Application Details - K153749

Device Classification Name Light, Ultraviolet, Dermatological

  More FDA Info for this Device
510(K) Number K153749
Device Name Light, Ultraviolet, Dermatological
Applicant DAAVLIN DISTRIBUTING COMPANY
205 WEST BEMENT STREET
BRYAN, OH 43506 US
Other 510(k) Applications for this Company
Contact MICHELE THIEL
Other 510(k) Applications for this Contact
Regulation Number 878.4630

  More FDA Info for this Regulation Number
Classification Product Code FTC
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 12/29/2015
Decision Date 06/30/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact