510(k) K873984
K873984 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)". The FDA issued a decision of Substantially Equivalent on October 20, 1987. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1987
- Date Received
- September 30, 1987
- 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