The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Palmlight 10, Model 001-00030.
Device ID | K061341 |
510k Number | K061341 |
Device Name: | PALMLIGHT 10, MODEL 001-00030 |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | CAO GROUP, INC. 8683 SOUTH 700 WEST Sandy, UT 84070 |
Contact | Robert K Larsen |
Correspondent | Robert K Larsen CAO GROUP, INC. 8683 SOUTH 700 WEST Sandy, UT 84070 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-15 |
Decision Date | 2006-06-12 |
Summary: | summary |