510(k) K072372
K072372 is an FDA 510(k) premarket notification submitted by Mego Afek for the device "PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE". The FDA issued a decision of Substantially Equivalent on November 21, 2007. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Mego Afek has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2007
- Date Received
- August 23, 2007
- 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