510(k) K871789
K871789 is an FDA 510(k) premarket notification submitted by Mercury Enterprises, Inc. for the device "INTECARE PEDIATRIC URINE COLLECTOR". The FDA issued a decision of Substantially Equivalent on August 10, 1987. The device falls under product code FFH (Collector, Urine, Pediatric, For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Mercury Enterprises, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1987
- Date Received
- May 6, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collector, Urine, Pediatric, For Indwelling Catheter
- Device Class
- Class II
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type