TYMPANOSTOMY TUBE— 510(k) K082188
Substantially EquivalentAcclarent, Inc.
FDA 510(k) clearance K082188 for TYMPANOSTOMY TUBE, Substantially Equivalent on 2008-09-19. Applicant: Acclarent, Inc.. Device class: 2.
Clearance details
- Applicant
- Acclarent, Inc.
- Product code
- Code ETD
- Device class
- Class 2
- Regulation
- 21 CFR 874.3880
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rmenlo Park, CA, US
Recent devices under product code ETD
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- K232702 — Solo+ Tympanostomy Tube Device (TTD)
- K233658 — Biowy Tym Tube (TT)
- K232059 — Tympanostomy Tubes
More clearances from Acclarent, Inc.
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