The following data is part of a premarket notification filed by New World Imports, Inc. with the FDA for Crutch Tips, Pads & Hand Grips.
| Device ID | K800076 |
| 510k Number | K800076 |
| Device Name: | CRUTCH TIPS, PADS & HAND GRIPS |
| Classification | Tips And Pads, Cane, Crutch And Walker |
| Applicant | NEW WORLD IMPORTS, 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 | 1980-01-14 |
| Decision Date | 1980-01-28 |