510(k) K801796
K801796 is an FDA 510(k) premarket notification submitted by Gettner Enterprises, Inc. for the device "THE COMFORT LIFT". The FDA issued a decision of Substantially Equivalent on Aug 13, 1980. The device falls under product code FMR (Device, Transfer, Patient, Manual), a Class I device regulated under 21 CFR 880.6785.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 1980
- Date Received
- Jul 29, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Transfer, Patient, Manual
- Device Class
- Class I
- Regulation Number
- 880.6785
- Review Panel
- HO
- Submission Type