510(k) K760374
K760374 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "DIALYZER (MODEL 1850)". The FDA issued a decision of Substantially Equivalent on October 27, 1976. 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
- October 27, 1976
- Date Received
- August 5, 1976
- 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