The following data is part of a premarket notification filed by Husa Folding Crutch Co., Inc. with the FDA for Folding Crutch.
Device ID | K800237 |
510k Number | K800237 |
Device Name: | FOLDING CRUTCH |
Classification | Crutch |
Applicant | HUSA FOLDING CRUTCH CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IPR |
CFR Regulation Number | 890.3150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-05 |
Decision Date | 1980-02-22 |