The following data is part of a premarket notification filed by Greene International Corp. with the FDA for Standard Wheelchair.
Device ID | K842719 |
510k Number | K842719 |
Device Name: | STANDARD WHEELCHAIR |
Classification | Wheelchair, Special Grade |
Applicant | GREENE INTERNATIONAL CORP. 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 | 1984-07-13 |
Decision Date | 1984-07-25 |