510(k) K010096

MULTI CARE THERAPEUTIC VIBRATOR by Multicept A/S — Product Code KXQ

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