510(k) K883239
K883239 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS". The FDA issued a decision of Substantially Equivalent on Oct 21, 1988. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 21, 1988
- Date Received
- Aug 1, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Set, Administration, For Peritoneal Dialysis, Disposable
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type
- 510(k)