The following data is part of a premarket notification filed by First Industries, Inc. with the FDA for Crutch Tips & Grips.
Device ID | K810650 |
510k Number | K810650 |
Device Name: | CRUTCH TIPS & GRIPS |
Classification | Tips And Pads, Cane, Crutch And Walker |
Applicant | FIRST INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | INP |
CFR Regulation Number | 890.3790 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-10 |
Decision Date | 1981-03-26 |