Strome-Blitzer Cytology Balloon— 510(k) K182159
Substantially EquivalentAdn International, LLC
FDA 510(k) clearance K182159 for Strome-Blitzer Cytology Balloon, Substantially Equivalent on 2019-06-13. Applicant: Adn International, LLC. Device class: 2.
Clearance details
- Applicant
- Adn International, LLC
- Product code
- Code EOX
- Device class
- Class 2
- Regulation
- 21 CFR 874.4710
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code EOX
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