45 Micron Polyisoprene Condom
FDA 510(k) clearance K231908 · decided 2023-10-27
Clearance details
- K-number
- K231908
- Device name
- 45 Micron Polyisoprene Condom
- Applicant
- Suretex Limited
- Decision
- Substantially Equivalent
- Date received
- 2023-06-29
- Decision date
- 2023-10-27
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- MOL
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Tambon Khao Kwai, Amphur Phunphin, TH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.