The following data is part of a premarket notification filed by Pride Health Care, Inc. with the FDA for Legend Sc 300.
Device ID | K926295 |
510k Number | K926295 |
Device Name: | LEGEND SC 300 |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | PRIDE HEALTH CARE, INC. 71 S. MAIN ST. Pittston, PA 18640 |
Contact | Thomas Kretchik |
Correspondent | Thomas Kretchik PRIDE HEALTH CARE, INC. 71 S. MAIN ST. Pittston, PA 18640 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-14 |
Decision Date | 1994-03-28 |