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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, aspirating, bronchoscope, rigid
Regulation Description Bronchoscope (flexible or rigid) and accessories.
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeKTR
Regulation Number 874.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT - KIT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2

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