510(k) K863281
K863281 is an FDA 510(k) premarket notification submitted by Welmed Systems, Inc. for the device "CARE + PLUS IRREGATION TRAY". The FDA issued a decision of Substantially Equivalent on October 31, 1986. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Welmed Systems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1986
- Date Received
- August 25, 1986
- 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