K250256

Substantially Equivalent

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))

Applicant: Aventamed Dac
Product code: ETD
Advisory panel: Ear, Nose, Throat
Date received: 2025-01-28
Decision date: 2025-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bishopstown, IE

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