LATERA Absorbable Nasal Implant System— 510(k) K192661
Substantially EquivalentEntellus Medical, Inc. (Aka Stryker Ent)
FDA 510(k) clearance K192661 for LATERA Absorbable Nasal Implant System, Substantially Equivalent on 2019-11-10. Applicant: Entellus Medical, Inc. (Aka Stryker Ent). Device class: 2.
Clearance details
- Applicant
- Entellus Medical, Inc. (Aka Stryker Ent)
- Product code
- Code NHB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Plymouth, MN, US
Recent devices under product code NHB
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