The following data is part of a premarket notification filed by Poirier S.a. with the FDA for Children's Wheelchairs.
Device ID | K840636 |
510k Number | K840636 |
Device Name: | CHILDREN'S WHEELCHAIRS |
Classification | Wheelchair, Special Grade |
Applicant | POIRIER S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IQC |
CFR Regulation Number | 890.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-20 |
Decision Date | 1984-02-27 |