510(k) K991456
K991456 is an FDA 510(k) premarket notification submitted by Microwave Medical, Inc. for the device "MICROWAVE DELIVERY SYSTEM, MODEL MMC-300". The FDA issued a decision of Substantially Equivalent on October 25, 1999. 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
- October 25, 1999
- Date Received
- April 26, 1999
- Clearance Type
- Traditional
- 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