510(k) K911577
K911577 is an FDA 510(k) premarket notification submitted by Martin Mclane Medical for the device "HYPOTRANS MODEL 750". The FDA issued a decision of Substantially Equivalent on July 8, 1992. The device falls under product code KDK (Container, Transport, Kidney), a Class II device regulated under 21 CFR 876.5880.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 1992
- Date Received
- April 8, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Transport, Kidney
- Device Class
- Class II
- Regulation Number
- 876.5880
- Review Panel
- GU
- Submission Type