The following data is part of a premarket notification filed by Golden Technologies, Inc. with the FDA for Companion Model 221, 321, 421.
| Device ID | K012258 |
| 510k Number | K012258 |
| Device Name: | COMPANION MODEL 221, 321, 421 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | GOLDEN TECHNOLOGIES, INC. 401 BRIDGE ST. Old Forge, PA 18518 |
| Contact | Fred Kiwak |
| Correspondent | Fred Kiwak 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 | 2001-07-18 |
| Decision Date | 2001-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B247GR595 | K012258 | 000 |