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U.S. Department of Health and Human Services

Product Classification

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Device diathermy, microwave, for use other than applying therapeutic deep heat
Regulation Description Microwave diathermy.
Definition PMAs to be filed by 7/13/99 (64 FR 18331 (4/14/99))
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeHPH
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type PMA
Regulation Number 890.5275
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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