510(k) K934419
K934419 is an FDA 510(k) premarket notification submitted by Urological Associates of Central Jersey P.A. for the device "URETERAL CATHETER AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on May 25, 1994. The device falls under product code EYK (Connector, Ureteral Catheter), a Class I device regulated under 21 CFR 876.5130.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 1994
- Date Received
- September 13, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Connector, Ureteral Catheter
- Device Class
- Class I
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type