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U.S. Department of Health and Human Services

Product Classification

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Device tube, tympanostomy, porous polyethylene
Regulation Description Tympanostomy tube.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeLBL
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Ear, Nose, and Throat Devices Branch (ENTB)
Submission Type 510(k)
Regulation Number 874.3880
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification; Final [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080204.pdf] 
Third Party Review Not Third Party Eligible
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