The following data is part of a premarket notification filed by Mobility Products & Design with the FDA for Hand Controls, Model 3700 And 3500 Series.
Device ID | K900416 |
510k Number | K900416 |
Device Name: | HAND CONTROLS, MODEL 3700 AND 3500 SERIES |
Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
Applicant | MOBILITY PRODUCTS & DESIGN 14800 28TH AVENUE NORTH Plymouth, MN 55447 |
Contact | Kenneth B Herland |
Correspondent | Kenneth B Herland MOBILITY PRODUCTS & DESIGN 14800 28TH AVENUE NORTH Plymouth, MN 55447 |
Product Code | IPQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-30 |
Decision Date | 1990-05-30 |