510(k) K003916
K003916 is an FDA 510(k) premarket notification submitted by Scandia Manufacturing , Ltd. for the device "DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 15, 2002. The device falls under product code IMB (Cabinet, Moist Steam), a Class II device regulated under 21 CFR 890.5250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2002
- Date Received
- December 19, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cabinet, Moist Steam
- Device Class
- Class II
- Regulation Number
- 890.5250
- Review Panel
- PM
- Submission Type