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U.S. Department of Health and Human Services

Product Classification

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Device microdebrider, ent, high speed, single use, reprocessed
Regulation Description Ear, nose, and throat bur.
Definition Ent microdebrider is an accessory to an ent drill system.It is intended to remove soft and hard tissue during ear, nost and throat surgery.These devices operate at high speed for precise tissue resection.(this is for reprocessed sing use ent microdebrider.).
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeNLY
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 874.4140
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible