The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Den-mat Fiber Optic Halogen Light.
Device ID | K802716 |
510k Number | K802716 |
Device Name: | DEN-MAT FIBER OPTIC HALOGEN LIGHT |
Classification | Light, Fiber Optic, Dental |
Applicant | DEN-MAT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EAY |
CFR Regulation Number | 872.4620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-31 |
Decision Date | 1980-11-12 |