The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Ascent 3d.
Device ID | K150585 |
510k Number | K150585 |
Device Name: | Ascent 3D |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan, UT 84084 |
Contact | Robert K Larsen |
Correspondent | Robert K Larsen CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan, UT 84084 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-09 |
Decision Date | 2015-12-31 |