The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Compression Sleeves.
| Device ID | K060049 |
| 510k Number | K060049 |
| Device Name: | REPROCESSED COMPRESSION SLEEVES |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Moira Barton |
| Correspondent | Moira Barton ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST 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 | 2006-01-06 |
| Decision Date | 2006-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885825017137 | K060049 | 000 |
| 50885825017120 | K060049 | 000 |
| 50885825017076 | K060049 | 000 |
| 50885825017069 | K060049 | 000 |
| 50885825017052 | K060049 | 000 |
| 50885825017045 | K060049 | 000 |
| 50885825017038 | K060049 | 000 |