The following data is part of a premarket notification filed by Knochen Dental Laboratory with the FDA for X-ray Collimator X-cjd.
Device ID | K834606 |
510k Number | K834606 |
Device Name: | X-RAY COLLIMATOR X-CJD |
Classification | Collimator, X-ray |
Applicant | KNOCHEN DENTAL LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EHB |
CFR Regulation Number | 872.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-28 |
Decision Date | 1984-02-21 |