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U.S. Department of Health and Human Services

Product Classification

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Device forceps, biopsy, bronchoscope (non-rigid), reprocessed
Regulation Description Bronchoscope (flexible or rigid) and accessories.
Definition Same as bwh except it is reprocessed.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeNLE
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 874.4680
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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