510(k) K013707
K013707 is an FDA 510(k) premarket notification submitted by Global TV Concepts, Ltd. for the device "SOFTIQUE, MODEL GI 11001". The FDA issued a decision of Substantially Equivalent on February 1, 2002. The device falls under product code IMC (Bath, Paraffin), a Class II device regulated under 21 CFR 890.5110. Global TV Concepts, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 2002
- Date Received
- November 8, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bath, Paraffin
- Device Class
- Class II
- Regulation Number
- 890.5110
- Review Panel
- PM
- Submission Type