The following data is part of a premarket notification filed by General X-ray, Inc. with the FDA for X-ray Collimator.
Device ID | K781675 |
510k Number | K781675 |
Device Name: | X-RAY COLLIMATOR |
Classification | Collimator, X-ray |
Applicant | GENERAL X-RAY, INC. 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 | 1978-09-29 |
Decision Date | 1978-12-04 |