The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Personal Knee Crutch Pad.
Device ID | K831149 |
510k Number | K831149 |
Device Name: | PERSONAL KNEE CRUTCH PAD |
Classification | Tips And Pads, Cane, Crutch And Walker |
Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 368 FAIRVIEW AVE. Hammonton, NJ 08037 -0268 |
Product Code | INP |
CFR Regulation Number | 890.3790 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-08 |
Decision Date | 1983-05-03 |