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U.S. Department of Health and Human Services

Product Classification
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Device led lamps emitting visible light intended to be used for illumination purposes
Definition LED lamps emitting predominantly visible and/or white light intended to be used for illumination purposes. These include illumination products, flashlights, finished bulbs or lamps.
Product CodeRHH
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Summary Malfunction
Reporting		 Ineligible
Third Party Review Not Third Party Eligible
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