The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Nupro Model 13016901.
Device ID | K103160 |
510k Number | K103160 |
Device Name: | NUPRO MODEL 13016901 |
Classification | Varnish, Cavity |
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 | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2010-10-26 |
Decision Date | 2011-01-06 |
Summary: | summary |