510(k) K012258
K012258 is an FDA 510(k) premarket notification submitted by Golden Technologies, Inc. for the device "COMPANION MODEL 221, 321, 421". The FDA issued a decision of Substantially Equivalent on December 3, 2001. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Golden Technologies, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2001
- Date Received
- July 18, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vehicle, Motorized 3-Wheeled
- Device Class
- Class II
- Regulation Number
- 890.3800
- Review Panel
- PM
- Submission Type