510(k) K924981
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 1993
- Date Received
- October 1, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Cholangiography
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type