510(k) K053208
CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET by
Swemed Lab International AB
— Product Code MQF
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2006
- Date Received
- November 16, 2005
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6110
- Review Panel
- OB
- Submission Type