510(k) K883058
K883058 is an FDA 510(k) premarket notification submitted by Solco Basle, Inc. for the device "SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 28, 1988. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Solco Basle, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1988
- Date Received
- July 19, 1988
- 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