FEMEYE TWO
FDA 510(k) clearance K093218 · decided 2010-05-18
Clearance details
- K-number
- K093218
- Device name
- FEMEYE TWO
- Applicant
- Fem Suite, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-10-13
- Decision date
- 2010-05-18
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Sonoma, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.