510(k) K855209
K855209 is an FDA 510(k) premarket notification submitted by Mali, Inc. for the device "NIR LAT MALE EXTERNAL CATHETER". The FDA issued a decision of Substantially Equivalent on Jan 10, 1986. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Mali, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 10, 1986
- Date Received
- Dec 30, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Collector, Urine, (And Accessories) For Indwelling Catheter
- Device Class
- Class II
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type
- 510(k) Exempt