The following data is part of a premarket notification filed by Gettner Enterprises, Inc. with the FDA for The Comfort Lift.
Device ID | K801796 |
510k Number | K801796 |
Device Name: | THE COMFORT LIFT |
Classification | Device, Transfer, Patient, Manual |
Applicant | GETTNER ENTERPRISES, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | FMR |
CFR Regulation Number | 880.6785 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-07-29 |
Decision Date | 1980-08-13 |