The following data is part of a premarket notification filed by Sunrise Technologies, Inc. with the FDA for Sunrise Curing Lamp.
Device ID | K962192 |
510k Number | K962192 |
Device Name: | SUNRISE CURING LAMP |
Classification | Material, Tooth Shade, Resin |
Applicant | SUNRISE TECHNOLOGIES, INC. 47257 FREMONT BLVD. Fremont, CA 94538 |
Contact | Carol Kim |
Correspondent | Carol Kim SUNRISE TECHNOLOGIES, INC. 47257 FREMONT BLVD. Fremont, CA 94538 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-07 |
Decision Date | 1996-09-03 |
Summary: | summary |