Proprietary Name: |
Trojan ENZ Armor Condom; Trojan Her Pleasure Lubricated Condom; Trojan Her Pleasure Sensations Armor Condom; Trojan Her Pleasure Sensations Lubricated; Trojan Her Pleasure Sensations Spermicidal; Trojan Her Pleasure Warm Sensations; Trojan Intensified Charged; Trojan Pleasures Fire & Ice Dual Action Lubricant; Trojan Sensitivity Ultra Thin Armor Condom; Trojan Sensitivity Ultra Thin Spermicidal; Trojan Stimulations Intense Ribbed Ultrasmooth Lubricated; Trojan Stimulations Twisted Pleasure; Trojan Stimulations Ultra Ribbed Armor Condom; Trojan The Edge Changing Sensations Condom; Trojan Ultra ENZ Comfort; Trojan ULTRAFIT FREEDOM FEEL Condom; Trojan ULTRAFIT SENSITIVE TIP FEEL Condom |
Classification Name: |
CONDOM WITH NONOXYNOL-9 |
Product Code: |
LTZ |
Device Class: |
2 |
Regulation Number: |
884.5310 |
Medical Specialty: |
Obstetrics/Gynecology |
Registered Establishment Name: |
Church & Dwight Manufacturing Co., Inc.
|
Registered Establishment Number: |
1122329
|
Premarket Submission Number: |
K912901 |
Owner/Operator: |
CHURCH & DWIGHT CO., INC. |
Owner/Operator Number: |
2210299
|
Establishment Operations: |
Manufacturer; Repackager/Relabeler
|