One Touch Spiral Condom
FDA 510(k) clearance K210294 · decided 2021-09-23
Clearance details
- K-number
- K210294
- Device name
- One Touch Spiral Condom
- Applicant
- Thai Nippon Rubber Industry Public Company Limited.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-02
- Decision date
- 2021-09-23
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- HIS
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Sriracha, TH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.