0.04 ZERO ZERO FOUR Male Latex Condom
Okamoto USA, Inc. · Obstetrics/Gynecology
Open FDA's page for this record- Third party flag
- N
- City
- Sandusky
- Advisory committee description
- Obstetrics/Gynecology
- Address 1
- 3130 W. Monroe St.
- Statement or summary
- Summary
- Product code
- HIS
- Zip code
- 44870
- Applicant
- Okamoto USA, Inc.
- Decision date
- 2025-02-18
- Decision code
- SESE
- Country code
- US
- Device name
- 0.04 ZERO ZERO FOUR Male Latex Condom
- Advisory committee
- OB
- Contact
- Kenji Komatsu
- K number
- K243584
- State
- OH
- Date received
- 2024-11-20
- Review advisory committee
- OB
- Postal code
- 44870
- Decision description
- Substantially Equivalent
- Clearance type
- Abbreviated
- Harmonized identifiers (openFDA)
- Device name
- Condom
- Medical specialty description
- Obstetrics/Gynecology
- Regulation number
- 884.5300
- Device class
- 2
- Registration number
- 2086832, 3002997683, 8044081, 3003823186, 3003902978, 3008062466, 3013770781, 3013408180, 1054241, 3004785585, 2938651, 3008808138, 8040211, 3003727136, 3039878168, 3003370588, 3003592318, 9610410, 3011015568, 9613932, 3007829481, 3042262517, 1043214, 3006479639, 2531449, 2020372, 3003491851, 3003759643, 3015729142, 3007671445, 3026885377, 3003169402, 3006122980, 1055236, 9616578, 2280705, 9616515, 3007962592, 9611836, 3007307589 +35 more
- FEI number
- 3009084570, 1000535235, 3003979157, 3002997683, 3003823186, 3003902978, 3008062466, 3013770781, 3013408180, 3004785585, 2938651, 3008808138, 3003727136, 3039878168, 3003370588, 3003592318, 3332, 3011015568, 3007829481, 3002260664, 3042262517, 1043214, 3006479639, 2020372, 3003491851, 3003759643, 2025773, 3002808272, 3015729142, 3007671445, 3026885377, 3003169402, 3006122980, 3005203207, 1000112877, 2280705, 3003040625, 3003055110, 1000306431, 3007962592 +35 more