The following data is part of a premarket notification filed by Golden Technologies, Inc. with the FDA for Golden Spyder, Model Gs-300.
Device ID | K041341 |
510k Number | K041341 |
Device Name: | GOLDEN SPYDER, MODEL GS-300 |
Classification | Wheelchair, Powered |
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 | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-20 |
Decision Date | 2004-06-03 |
Summary: | summary |