510(k) K811228
K811228 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "SORENSON CATALOG #IFL-120S". The FDA issued a decision of Substantially Equivalent on June 9, 1981. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Sorensen Research has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1981
- Date Received
- May 4, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Autotransfusion
- Device Class
- Class II
- Regulation Number
- 868.5830
- Review Panel
- CV
- Submission Type