The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Tourniwrap Bandage.
Device ID | K760576 |
510k Number | K760576 |
Device Name: | TOURNIWRAP BANDAGE |
Classification | Stocking, Elastic |
Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILG |
CFR Regulation Number | 890.3475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-03 |
Decision Date | 1976-10-05 |