510(k) K862722
K862722 is an FDA 510(k) premarket notification submitted by Mercury Enterprises, Inc. for the device "TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE". The FDA issued a decision of Substantially Equivalent on August 11, 1986. The device falls under product code FKY (Connector, Tubing, Dialysate), a Class II device regulated under 21 CFR 876.5820. Mercury Enterprises, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 1986
- Date Received
- July 17, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Connector, Tubing, Dialysate
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type