510(k) K010096
- Device
- MULTI CARE THERAPEUTIC VIBRATOR
- Applicant
- MULTICEPT A/S
- 510(k) number
- K010096
- Product code
- KXQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-03-05
- Date received
- 2001-01-11
- Regulation
- 884.5960
- Classification name
- Vibrator For Therapeutic Use, Genital
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KLAUS VAMMEN
- Address
- Lyngsoe Alle 3,1 Hoersholm DK 2970 2970
FDA Registration Numbers#
- 3014686987
- 3042277215
- 3020284548
- 3023395601
- 3008469990
- 3017889736
- 3012477715
- 3012759464
- 3039346136
- 3012900326
- 3010975837
- 3016784194
- 3022568093
- 3003700453
- 3014657561
- 8040494
- 3011630465
- 3026270764
- 3024843804
- 3011905669
- 3016725159
- 3023054050
- 3011353016
- 3016159407
- 3012110942
- 3016171962
- 3013909820
- 3012074930
- 3014326210
- 3010511300
- 3042254879
- 3016147813
- 3027645761
- 3017994919
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KXQ #
Legacy Summary#
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FDA Review#
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