TULA Iontophoresis System with Earset— 510(k) K150453
Substantially EquivalentAcclarent, Inc.
FDA 510(k) clearance K150453 for TULA Iontophoresis System with Earset, Substantially Equivalent on 2015-05-20. Applicant: Acclarent, Inc.. Device class: 2.
Clearance details
- Applicant
- Acclarent, Inc.
- Product code
- Code EGJ
- Device class
- Class 2
- Regulation
- 21 CFR 890.5525
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rmenlo Park, CA, US
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