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U.S. Department of Health and Human Services

Product Classification
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Device laser illuminated projector
Definition A full-frame digital image projector which incorporates lasers and possibly other light sources to illuminate image processing components.
Product CodeRIG
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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