510(k) K852764
K852764 is an FDA 510(k) premarket notification submitted by Trans-National Trade Development Corp. for the device "IDECAP DIALYZER". The FDA issued a decision of Substantially Equivalent on September 20, 1985. The device falls under product code FJH (Dialyzer, Disposable), a Class II device regulated under 21 CFR 876.5830. Trans-National Trade Development Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1985
- Date Received
- June 28, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialyzer, Disposable
- Device Class
- Class II
- Regulation Number
- 876.5830
- Review Panel
- GU
- Submission Type