The following data is part of a premarket notification filed by Alba-waldensian, Inc. with the FDA for Alba Health Pas Wrap System.
| Device ID | K961405 |
| 510k Number | K961405 |
| Device Name: | ALBA HEALTH PAS WRAP SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ALBA-WALDENSIAN, INC. 201 ST. GERMAIN AVE., S.W. Valdese, NC 28690 |
| Contact | Victor H Garrou |
| Correspondent | Victor H Garrou ALBA-WALDENSIAN, INC. 201 ST. GERMAIN AVE., S.W. Valdese, NC 28690 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-11 |
| Decision Date | 1996-12-26 |
| Summary: | summary |