510(k) K830359
K830359 is an FDA 510(k) premarket notification submitted by Welcon, Inc. for the device "STERILE CATHERIZATION PROCEDURE TRAYS". The FDA issued a decision of Substantially Equivalent on March 17, 1983. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Welcon, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1983
- Date Received
- February 3, 1983
- 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