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U.S. Department of Health and Human Services

Product Classification

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Device hammer, reflex, powered
Regulation Description Powered reflex hammer.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeIKO
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 890.1450
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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