VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
FDA 510(k) clearance K051438 · decided 2006-04-04
Clearance details
- K-number
- K051438
- Device name
- VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
- Applicant
- Alliance Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-01
- Decision date
- 2006-04-04
- Days to decision
- 307 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hill-Rom Foot Garment - Reprocessed Sterile device -- Compressible limb sleeve. recall (Z-1665-2008) | Ascent Healthcare Solutions, Inc. | 2008-09-19 |