510(k) K943752
K943752 is an FDA 510(k) premarket notification submitted by Rimeco Products, Inc. for the device "RIMECO MIDSTREAM URINE COLLECTOR". The FDA issued a decision of Substantially Equivalent on November 1, 1994. The device falls under product code FOC (Bag, Urine Collection, Newborn), a Class II device regulated under 21 CFR 876.5250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 1994
- Date Received
- August 2, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Urine Collection, Newborn
- Device Class
- Class II
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type