510(k) K091495
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A by
Olympus Medical Systems Corporation
— Product Code LQR
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 2009
- Date Received
- May 20, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dislodger, Stone, Biliary
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type