510(k) K923848
K923848 is an FDA 510(k) premarket notification submitted by Goosen Enterprises, Inc. for the device "GOOSEN SELF-LUBRICATING CATHETER". The FDA issued a decision of Substantially Equivalent on February 18, 1994. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Goosen Enterprises, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1994
- Date Received
- July 31, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type