PAPARELL TYPE 2, BIOLITE COATED SILI-— 510(k) K800728
Substantially EquivalentXomed, Inc.
FDA 510(k) clearance K800728 for PAPARELL TYPE 2, BIOLITE COATED SILI-, Substantially Equivalent on 1980-04-16. Applicant: Xomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Xomed, 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
- Arnold, MO, US
Recent devices under product code ETD
view all- K252436 — Tula Tympanostomy Tube Delivery Device
- K250256 — Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
- K232702 — Solo+ Tympanostomy Tube Device (TTD)
- K233658 — Biowy Tym Tube (TT)
- K232059 — Tympanostomy Tubes
More clearances from Xomed, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.