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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assisted reproduction laminar flow workstation
Definition This product code is a class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Product CodeQKH
Regulation Number 884.6120
Device Class 2

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