FDA 510(k) Application Details - K101366

Device Classification Name Massager, Vacuum, Light Induced Heating

  More FDA Info for this Device
510(K) Number K101366
Device Name Massager, Vacuum, Light Induced Heating
Applicant CHROMOGENEX TECHNOLOGIES LTD
UNITS 1&2 HEOL RHOSYN,
PARC DAFEN
LLANELLI, CARMARTHENSHIRE SA148QG GB
Other 510(k) Applications for this Company
Contact PETER R BEVAN
Other 510(k) Applications for this Contact
Regulation Number 878.4810

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

  More FDA Info for this Product Code
Date Received 05/17/2010
Decision Date 09/17/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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