The following data is part of a premarket notification filed by Novaf Andalucia 2007, Sl with the FDA for Mechanical Wheelchair.
Device ID | K120302 |
510k Number | K120302 |
Device Name: | MECHANICAL WHEELCHAIR |
Classification | Wheelchair, Special Grade |
Applicant | NOVAF ANDALUCIA 2007, SL CAMINO SE SANTA TERESA NAVE 1 Rota, ES Pc 11520 |
Contact | Fernando Saenz De Santamaria |
Correspondent | Fernando Saenz De Santamaria NOVAF ANDALUCIA 2007, SL CAMINO SE SANTA TERESA NAVE 1 Rota, ES Pc 11520 |
Product Code | IQC |
CFR Regulation Number | 890.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-01 |
Decision Date | 2012-07-06 |
Summary: | summary |