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U.S. Department of Health and Human Services

Product Classification

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Device retractor, self-retaining, for neurosurgery
Regulation Description Self-retaining retractor for neurosurgery.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGZT
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
Submission Type 510(k)
Regulation Number 882.4800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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