The following data is part of a premarket notification filed by Vidacare Corporation with the FDA for Vertebral Access System By Vidacare.
Device ID | K081713 |
510k Number | K081713 |
Device Name: | VERTEBRAL ACCESS SYSTEM BY VIDACARE |
Classification | Battery, Replacement, Rechargeable |
Applicant | VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvine, CA 92606 |
Contact | Grace Holland |
Correspondent | Grace Holland VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvine, CA 92606 |
Product Code | MOQ |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-17 |
Decision Date | 2008-11-21 |
Summary: | summary |