The following data is part of a premarket notification filed by Alpha Unlimited, Inc. with the FDA for Alpha Push Kart.
Device ID | K841911 |
510k Number | K841911 |
Device Name: | ALPHA PUSH KART |
Classification | Chair, With Casters |
Applicant | ALPHA UNLIMITED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | INM |
CFR Regulation Number | 890.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-09 |
Decision Date | 1984-05-23 |