510(k) K812811
K812811 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "MICROCOIL 80 DIALYZER". The FDA issued a decision of Substantially Equivalent on December 3, 1981. The device falls under product code FHS (Dialyzer, Single Coil), a Class II device regulated under 21 CFR 876.5820. Erika, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1981
- Date Received
- October 6, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialyzer, Single Coil
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type