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U.S. Department of Health and Human Services

Product Classification

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Device laser, neodymium:yag, pulmonary surgery
Regulation Description Ear, nose, and throat microsurgical carbon dioxide laser.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Anesthesiology
Product CodeLLO
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 874.4500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Guidance Document
Third Party Review
Accredited Persons
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