OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE
FDA 510(k) clearance K053494 · decided 2006-03-23
Clearance details
- K-number
- K053494
- Device name
- OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE
- Applicant
- Fertipro NV
- Decision
- Substantially Equivalent
- Date received
- 2005-12-15
- Decision date
- 2006-03-23
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.