The following data is part of a premarket notification filed by Medical Modeling Inc. with the FDA for Vsp System.
Device ID | K133907 |
510k Number | K133907 |
Device Name: | VSP SYSTEM |
Classification | Driver, Wire, And Bone Drill, Manual |
Applicant | MEDICAL MODELING INC. 555 THIRTEENTH STREET NW Washington, DC 20004 |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan MEDICAL MODELING INC. 555 THIRTEENTH STREET NW Washington, DC 20004 |
Product Code | DZJ |
CFR Regulation Number | 872.4120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-23 |
Decision Date | 2014-01-22 |
Summary: | summary |