The following data is part of a premarket notification filed by Garaventa Accessibility with the FDA for Garaventa Super-trac Tre-52.
Device ID | K020933 |
510k Number | K020933 |
Device Name: | GARAVENTA SUPER-TRAC TRE-52 |
Classification | Elevator, Wheelchair, Portable |
Applicant | GARAVENTA ACCESSIBILITY BOX 1769 Blain, WA 98231 -1769 |
Contact | Norm Cooper |
Correspondent | Norm Cooper GARAVENTA ACCESSIBILITY BOX 1769 Blain, WA 98231 -1769 |
Product Code | ING |
CFR Regulation Number | 890.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-22 |
Decision Date | 2002-04-04 |
Summary: | summary |