510(k) K833061
K833061 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "C-FLEX PENROSE DRAINAGE TUBE". The FDA issued a decision of Substantially Equivalent on November 7, 1983. The device falls under product code FFA (Tube, Drainage, Suprapubic), a Class II device regulated under 21 CFR 876.5090. Concept, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1983
- Date Received
- September 9, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Drainage, Suprapubic
- Device Class
- Class II
- Regulation Number
- 876.5090
- Review Panel
- GU
- Submission Type