The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Palmlight.
Device ID | K020057 |
510k Number | K020057 |
Device Name: | PALMLIGHT |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | CAO GROUP, INC. 8685 SOUTH 7TH WEST Sandy, UT 84070 |
Contact | Tracy S Best |
Correspondent | Tracy S Best CAO GROUP, INC. 8685 SOUTH 7TH 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 | 2002-01-08 |
Decision Date | 2002-08-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00872320003401 | K020057 | 000 |
00872320003043 | K020057 | 000 |