The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Solstice.
Device ID | K102621 |
510k Number | K102621 |
Device Name: | SOLSTICE |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
Contact | Wendy Garman |
Correspondent | Wendy Garman KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-13 |
Decision Date | 2011-01-28 |
Summary: | summary |