510(k) K110636
K110636 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "TULA IONTOPHORESIS SYSTEM". The FDA issued a decision of Substantially Equivalent on June 16, 2011. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Acclarent, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2011
- Date Received
- March 4, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Iontophoresis, Other Uses
- Device Class
- Class II
- Regulation Number
- 890.5525
- Review Panel
- PM
- Submission Type