The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Economy Immobilization And Velpean Sling.
Device ID | K760574 |
510k Number | K760574 |
Device Name: | ECONOMY IMMOBILIZATION AND VELPEAN SLING |
Classification | Sling, Arm |
Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILI |
CFR Regulation Number | 890.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-03 |
Decision Date | 1976-10-06 |