VOCALIS AND VOCALIS SM— 510(k) K081816
Substantially EquivalentCytophil, Inc.
FDA 510(k) clearance K081816 for VOCALIS AND VOCALIS SM, Substantially Equivalent on 2009-01-05. Applicant: Cytophil, Inc.. Device class: 2.
Clearance details
- Applicant
- Cytophil, Inc.
- Product code
- Code MIX
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Whitefish Bay, WI, US
Recent devices under product code MIX
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