510(k) K010096
K010096 is an FDA 510(k) premarket notification submitted by Multicept A/S for the device "MULTI CARE THERAPEUTIC VIBRATOR". The FDA issued a decision of Substantially Equivalent on March 5, 2001. The device falls under product code KXQ (Vibrator For Therapeutic Use, Genital), a Class II device regulated under 21 CFR 884.5960.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2001
- Date Received
- January 11, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vibrator For Therapeutic Use, Genital
- Device Class
- Class II
- Regulation Number
- 884.5960
- Review Panel
- OB
- Submission Type