The following data is part of a premarket notification filed by Venture Technology, Inc. with the FDA for Curing Light.
Device ID | K822654 |
510k Number | K822654 |
Device Name: | CURING LIGHT |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | VENTURE TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-02 |
Decision Date | 1982-10-04 |