510(k) K983022
K983022 is an FDA 510(k) premarket notification submitted by Harvest Technologies, LLC for the device "SMARTCELL PROCESSING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 2, 1999. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Harvest Technologies, LLC has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 1999
- Date Received
- August 31, 1998
- 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