The following data is part of a premarket notification filed by Alba-waldensian, Inc. with the FDA for Heel/elbow Protector.
| Device ID | K771913 |
| 510k Number | K771913 |
| Device Name: | HEEL/ELBOW PROTECTOR |
| Classification | Protector, Skin Pressure |
| Applicant | ALBA-WALDENSIAN, 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 | 1977-10-11 |
| Decision Date | 1977-11-15 |