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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
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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