The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Compressible Limb Sleeve.
| Device ID | K011192 |
| 510k Number | K011192 |
| Device Name: | COMPRESSIBLE LIMB SLEEVE |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Don Selvey |
| Correspondent | Don Selvey 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 | 2001-04-19 |
| Decision Date | 2001-11-26 |