510(k) K810500
K810500 is an FDA 510(k) premarket notification submitted by Delmed, Inc. for the device "BLOOD FREEZING BAG". The FDA issued a decision of Substantially Equivalent on September 23, 1981. The device falls under product code KSR (Container, Empty, For Collection & Processing Of Blood & Blood Components), a Class II device regulated under 21 CFR 864.9100. Delmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1981
- Date Received
- February 24, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Empty, For Collection & Processing Of Blood & Blood Components
- Device Class
- Class II
- Regulation Number
- 864.9100
- Review Panel
- HE
- Submission Type