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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mediastinoscope, surgical
Regulation Description Mediastinoscope 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 CodeEWY
Regulation Number 874.4720
Device Class 2


Premarket Reviews
ManufacturerDecision
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2

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