LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
FDA 510(k) clearance K221810 · decided 2022-10-31
Clearance details
- K-number
- K221810
- Device name
- LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
- Applicant
- Bonraybio Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-22
- Decision date
- 2022-10-31
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- MQK
- Device class
- 2
- Regulation number
- 884.6160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Taichung, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.