510(k) K896729
K896729 is an FDA 510(k) premarket notification submitted by Unoplast A/S for the device "NELATON-, FEMALE - OR TIEMANN CATHETER". The FDA issued a decision of Substantially Equivalent on November 5, 1990. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Unoplast A/S has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1990
- Date Received
- November 30, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urological
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type