The following data is part of a premarket notification filed by Moyco Industries, Inc. with the FDA for X-ray Shield.
Device ID | K833558 |
510k Number | K833558 |
Device Name: | X-RAY SHIELD |
Classification | Collimator, X-ray |
Applicant | MOYCO INDUSTRIES, 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 | 1983-10-13 |
Decision Date | 1984-01-13 |