The following data is part of a premarket notification filed by Everest & Jennings, Inc. with the FDA for Specialty Controls Interface.
Device ID | K913645 |
510k Number | K913645 |
Device Name: | SPECIALTY CONTROLS INTERFACE |
Classification | Wheelchair, Powered |
Applicant | EVEREST & JENNINGS, INC. 3233 E MISSION OAKS BLVD. Camarillo, CA 93010 |
Contact | Kackie Wilkins |
Correspondent | Kackie Wilkins EVEREST & JENNINGS, INC. 3233 E MISSION OAKS BLVD. Camarillo, CA 93010 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-16 |
Decision Date | 1991-12-17 |