The following data is part of a premarket notification filed by Denar Corp. with the FDA for Collimator Light Source.
Device ID | K924759 |
510k Number | K924759 |
Device Name: | COLLIMATOR LIGHT SOURCE |
Classification | Cone, Radiographic |
Applicant | DENAR CORP. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
Contact | Thomas J Muldoon |
Correspondent | Thomas J Muldoon DENAR CORP. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
Product Code | IZT |
CFR Regulation Number | 892.1610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-23 |
Decision Date | 1992-12-09 |