The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Elevator Cushion.
Device ID | K832472 |
510k Number | K832472 |
Device Name: | ELEVATOR CUSHION |
Classification | Operating Room Accessories Table Tray |
Applicant | INMED CORP. 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 | 1983-07-26 |
Decision Date | 1983-09-20 |