510(k) K073276
K073276 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "IONTOPHORESIS SYSTEM". The FDA issued a decision of Substantially Equivalent on March 5, 2008. 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
- March 5, 2008
- Date Received
- November 21, 2007
- 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