510(k) K853406
K853406 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO LUNDIA PRO 3 & 5 DIALYZER". The FDA issued a decision of Substantially Equivalent on Jan 8, 1986. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. Gambro, Inc. has 86 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 8, 1986
- Date Received
- Aug 12, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dialyzer, Parallel Flow
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type
- 510(k)