510(k) K010589
K010589 is an FDA 510(k) premarket notification submitted by Mw Medical, Inc. for the device "MICROWAVAE DELIVERY SYSTEM #MW2000". The FDA issued a decision of Substantially Equivalent on March 19, 2001. The device falls under product code MWY (System, Microwave, Hair Removal), a Class II device regulated under 21 CFR 878.4400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2001
- Date Received
- February 27, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Microwave, Hair Removal
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type