The following data is part of a premarket notification filed by Golden Technologies, Inc. with the FDA for Buzzaround, Vehicle, Motorized 3-wheeled.
| Device ID | K041025 |
| 510k Number | K041025 |
| Device Name: | BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | GOLDEN TECHNOLOGIES, INC. 401 BRIDGE ST. Old Forge, PA 18518 |
| Contact | Gene R Kulon |
| Correspondent | Gene R Kulon GOLDEN TECHNOLOGIES, INC. 401 BRIDGE ST. Old Forge, PA 18518 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-21 |
| Decision Date | 2004-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B247GB119 | K041025 | 000 |