The following data is part of a premarket notification filed by Alliance Medical, Inc. with the FDA for Vanguard Reprocessed Compression Garments (hill-rom).
| Device ID | K051438 |
| 510k Number | K051438 |
| Device Name: | VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ALLIANCE MEDICAL, INC. 10232 SOUTH 51 ST. Phoenix, AZ 85044 |
| Contact | Moira Barton |
| Correspondent | Moira Barton ALLIANCE MEDICAL, INC. 10232 SOUTH 51 ST. Phoenix, AZ 85044 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-01 |
| Decision Date | 2006-04-04 |
| Summary: | summary |