The following data is part of a premarket notification filed by Radiation Products Design, Inc. with the FDA for Adjustable Head & Face Holder.
Device ID | K800792 |
510k Number | K800792 |
Device Name: | ADJUSTABLE HEAD & FACE HOLDER |
Classification | Accelerator, Linear, Medical |
Applicant | RADIATION PRODUCTS DESIGN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-08 |
Decision Date | 1980-05-14 |