510(k) K944115
K944115 is an FDA 510(k) premarket notification submitted by Medtronic Hemotec, Inc. for the device "HEPARIN ASSAY CARTRIDGES AND CONTROLS". The FDA issued a decision of Substantially Equivalent on March 24, 1995. The device falls under product code GFT (Protamine Sulphate), a Class II device regulated under 21 CFR 864.7525. Medtronic Hemotec, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1995
- Date Received
- August 23, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protamine Sulphate
- Device Class
- Class II
- Regulation Number
- 864.7525
- Review Panel
- HE
- Submission Type