510(k) K941543
K941543 is an FDA 510(k) premarket notification submitted by Regulatory & Marketing Services, Inc. for the device "DIAL MEDICAL KIT". The FDA issued a decision of Substantially Equivalent (kit) on February 16, 1995. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Regulatory & Marketing Services, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- February 16, 1995
- Date Received
- March 30, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Blood Circuit, Hemodialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type