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 |