510(k) K053316
K053316 is an FDA 510(k) premarket notification submitted by Alliance Medical Corp. for the device "REPROCESSED COMPRESSION SLEEVES". The FDA issued a decision of Substantially Equivalent on February 13, 2006. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Alliance Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2006
- Date Received
- November 29, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type