Question No 28:
You are a German-based device manufacturer whose device is packaged in Ireland and sold in the US through a US-based company. The 510(k) was writtten by a contract organization. The label of our product may indicated any of the following EXCEPT"A. The principle place of business in the US
B. The packaging location address
C. The address of the contractor who submitted the 510(k)
D. The address of the distributor
Answer: C
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