The following data is part of a premarket notification filed by Arjo-century, Inc. with the FDA for Saf-lift/saf-kary.
Device ID | K926411 |
510k Number | K926411 |
Device Name: | SAF-LIFT/SAF-KARY |
Classification | Lift, Patient, Ac-powered |
Applicant | ARJO-CENTURY, INC. INDUSTRIAL PARK Aurora, NE 68818 |
Contact | James L Kadow |
Correspondent | James L Kadow ARJO-CENTURY, INC. INDUSTRIAL PARK Aurora, NE 68818 |
Product Code | FNG |
CFR Regulation Number | 880.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-21 |
Decision Date | 1993-03-31 |