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U.S. Department of Health and Human Services

Product Classification

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Device instrument, dowel cutting
Regulation Description Dowel cutting instrument.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGZQ
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.4275
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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