The following data is part of a premarket notification filed by Services Industriels Savaria, Inc. with the FDA for B.07 Stairway Chairlift.
Device ID | K024345 |
510k Number | K024345 |
Device Name: | B.07 STAIRWAY CHAIRLIFT |
Classification | Transport, Patient, Powered |
Applicant | SERVICES INDUSTRIELS SAVARIA, INC. 1225 EYE ST. N.W. SUITE 1150 Washington, DC 20005 |
Contact | Stephen Brophy |
Correspondent | Stephen Brophy SERVICES INDUSTRIELS SAVARIA, INC. 1225 EYE ST. N.W. SUITE 1150 Washington, DC 20005 |
Product Code | ILK |
CFR Regulation Number | 890.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-27 |
Decision Date | 2003-02-26 |
Summary: | summary |