The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Ascent F-coat Model: 006-00097.
| Device ID | K100540 |
| 510k Number | K100540 |
| Device Name: | ASCENT F-COAT MODEL: 006-00097 |
| Classification | Varnish, Cavity |
| Applicant | CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan, UT 84084 |
| Contact | Robert Larsen |
| Correspondent | Robert Larsen CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan, UT 84084 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-25 |
| Decision Date | 2010-09-23 |
| Summary: | summary |