The following data is part of a premarket notification filed by Everest & Jennings, Inc. with the FDA for Crs Ultralite Premier.
Device ID | K851257 |
510k Number | K851257 |
Device Name: | CRS ULTRALITE PREMIER |
Classification | Wheelchair, Mechanical |
Applicant | EVEREST & JENNINGS, INC. 3233 E MISSION OAKS BLVD. Camarillo, CA 93010 |
Contact | Molinelli |
Correspondent | Molinelli EVEREST & JENNINGS, INC. 3233 E MISSION OAKS BLVD. Camarillo, CA 93010 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-28 |
Decision Date | 1985-06-28 |