The following data is part of a premarket notification filed by Golden Technologies, Inc. with the FDA for Golden Eagle.
| Device ID | K971043 |
| 510k Number | K971043 |
| Device Name: | GOLDEN EAGLE |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | GOLDEN TECHNOLOGIES, INC. 401 BRIDGE ST. Old Forge, PA 18518 |
| Contact | Chris Mcconnell |
| Correspondent | Chris Mcconnell GOLDEN TECHNOLOGIES, INC. 401 BRIDGE ST. Old Forge, PA 18518 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-21 |
| Decision Date | 1997-08-01 |
| Summary: | summary |