510(k) K771349
K771349 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "MODIFICATION TO KIDNEY DIALYZER". The FDA issued a decision of Substantially Equivalent on August 2, 1977. 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
- August 2, 1977
- Date Received
- July 21, 1977
- 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