HSA-SOLUTION, MODEL 10034/10064
FDA 510(k) clearance K021896 · decided 2002-09-06
Clearance details
- K-number
- K021896
- Device name
- HSA-SOLUTION, MODEL 10034/10064
- Applicant
- Vitrolife Sweden AB
- Decision
- Substantially Equivalent
- Date received
- 2002-06-10
- Decision date
- 2002-09-06
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.