510(k) K831689
K831689 is an FDA 510(k) premarket notification submitted by Delmed, Inc. for the device "EMPTY DIALYSATE CONTAINER". The FDA issued a decision of Substantially Equivalent on August 11, 1983. The device falls under product code FKK (Clamp, Line), a Class I device regulated under 21 CFR 876.4730. Delmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 1983
- Date Received
- May 24, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Line
- Device Class
- Class I
- Regulation Number
- 876.4730
- Review Panel
- GU
- Submission Type