510(k) K100677
K100677 is an FDA 510(k) premarket notification submitted by Mego Afek AC , Ltd. for the device "LYMPHA PRESS 201MAX, MODEL 201MAX". The FDA issued a decision of Substantially Equivalent on May 20, 2010. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Mego Afek AC , Ltd. has 16 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2010
- Date Received
- Mar 10, 2010
- 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
- 510(k)