510(k) K791891
K791891 is an FDA 510(k) premarket notification submitted by Acumed Instruments Corp. for the device "ACU-MED RED MISER HEMOTHORAX BLOOD COLL.". The FDA issued a decision of Substantially Equivalent on December 5, 1979. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Acumed Instruments Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1979
- Date Received
- September 25, 1979
- 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