510(k) K863720
K863720 is an FDA 510(k) premarket notification submitted by Water Pure, Inc. for the device "HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on October 29, 1986. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Water Pure, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 1986
- Date Received
- September 23, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Subsystem, Water Purification
- Device Class
- Class II
- Regulation Number
- 876.5665
- Review Panel
- GU
- Submission Type