The following data is part of a premarket notification filed by Medpro, Inc. with the FDA for Heel/elbow Flotation Cushion.
Device ID | K760870 |
510k Number | K760870 |
Device Name: | HEEL/ELBOW FLOTATION CUSHION |
Classification | Protector, Skin Pressure |
Applicant | MEDPRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMP |
CFR Regulation Number | 880.6450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-18 |
Decision Date | 1976-11-01 |