Male Latex Condom HA— 510(k) K252622
Substantially EquivalentOkamoto USA, Inc.
FDA 510(k) clearance K252622 for Male Latex Condom HA, Substantially Equivalent on 2026-05-04. Applicant: Okamoto USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Okamoto USA, Inc.
- Product code
- Product code HIS
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Sandusky, OH, US
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More clearances from Okamoto USA, Inc.
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