The following data is part of a premarket notification filed by Pride Mobility Products Corp. with the FDA for Laser 3 Spsc300.
Device ID | K003058 |
510k Number | K003058 |
Device Name: | LASER 3 SPSC300 |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | PRIDE MOBILITY PRODUCTS CORP. 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
Contact | Gene R Kulon |
Correspondent | Gene R Kulon PRIDE MOBILITY PRODUCTS CORP. 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-02 |
Decision Date | 2001-03-08 |