The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Devon Head Rest.
Device ID | K840422 |
510k Number | K840422 |
Device Name: | DEVON HEAD REST |
Classification | Operating Room Accessories Table Tray |
Applicant | DEVON INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FWZ |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-31 |
Decision Date | 1984-03-12 |