510(k) K771862
K771862 is an FDA 510(k) premarket notification submitted by Medical, Inc. for the device "TRANSFUSION BLOOD FILTER". The FDA issued a decision of Substantially Equivalent on Oct 13, 1977. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Medical, Inc. has 21 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 13, 1977
- Date Received
- Oct 3, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Filter, Infusion Line
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)