510(k) K980917
ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR by
Fortune Medical Instrument Corp.
— Product Code GCA
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 1998
- Date Received
- March 11, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type