510(k) K090727
K090727 is an FDA 510(k) premarket notification submitted by Innovative Medical Manufacturing Co. for the device "IMM DENTAL IRRIGATION TUBING SET". The FDA issued a decision of Substantially Equivalent on Aug 13, 2009. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Innovative Medical Manufacturing Co. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 2009
- Date Received
- Mar 19, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Controller, Foot, Handpiece And Cord
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type
- 510(k)