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U.S. Department of Health and Human Services

Product Classification

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Device tong, skull for traction
Regulation Description Skull tongs for traction.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeHAX
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.5960
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
Third Party Review
Accredited Persons
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