A company A has bought a product line and the existing inventory from company B.
Company B delisted the product from their 510k listing.
Company A is not yet ready to manufacture the product (production line transfer not finished) but needs to continue distributing the device and would therefore list the new device.
However do they need to relabel the device under their own name or can they still distribute the device with the previous manufacturer's name on an FDA point of view ?
Thanks !
Company B delisted the product from their 510k listing.
Company A is not yet ready to manufacture the product (production line transfer not finished) but needs to continue distributing the device and would therefore list the new device.
However do they need to relabel the device under their own name or can they still distribute the device with the previous manufacturer's name on an FDA point of view ?
Thanks !
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