510(k) K771227
K771227 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "AK-10". The FDA issued a decision of Substantially Equivalent on August 2, 1977. The device falls under product code FIL (System, Dialysate Delivery, Single Pass), a Class II device regulated under 21 CFR 876.5820. Gambro, 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 7, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Dialysate Delivery, Single Pass
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type