COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS
FDA 510(k) clearance K082363 · decided 2009-04-29
Clearance details
- K-number
- K082363
- Device name
- COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS
- Applicant
- William A. Cook Australia Pty. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-18
- Decision date
- 2009-04-29
- Days to decision
- 254 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Eight Mile Plains, Qld, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.