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Accessory, Assisted Reproduction, Exempt

FDA product code PUB · 1 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 884.6120
Review panel
OB
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-01-14 – 2020-01-14

This product code is the 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.

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