510(k) K801634
K801634 is an FDA 510(k) premarket notification submitted by Bellco Artifidial Organ Spec., Inc. for the device "THE VITA 2 DISPOSABLE DIALYZER". The FDA issued a decision of Substantially Equivalent on Dec 17, 1980. The device falls under product code FHS (Dialyzer, Single Coil), a Class II device regulated under 21 CFR 876.5820. Bellco Artifidial Organ Spec., Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 17, 1980
- Date Received
- Jul 15, 1980
- 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
- 510(k)