ChitoZolve— 510(k) K181696
Substantially EquivalentGyrus Acmi, Inc.
FDA 510(k) clearance K181696 for ChitoZolve, Substantially Equivalent on 2018-11-30. Applicant: Gyrus Acmi, Inc.. Device class: 1.
Clearance details
- Applicant
- Gyrus Acmi, Inc.
- Product code
- Code LYA
- Device class
- Class 1
- Regulation
- 21 CFR 874.4780
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southborough, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.