510(k) K895631
K895631 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466". The FDA issued a decision of Substantially Equivalent on Jan 29, 1990. 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
- Jan 29, 1990
- Date Received
- Sep 19, 1989
- 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)