The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Chest Rolls.
Device ID | K780868 |
510k Number | K780868 |
Device Name: | CHEST ROLLS |
Classification | Table, Operating-room, Manual |
Applicant | DEVON INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FSE |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-05-30 |
Decision Date | 1978-08-14 |