510(k) K161316
K161316 is an FDA 510(k) premarket notification submitted by George King Bio-Medical, Inc. for the device "George King Coumadin Plasma". The FDA issued a decision of Substantially Equivalent on February 23, 2017. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. George King Bio-Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2017
- Date Received
- May 11, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plasma, Coagulation Control
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type