Grapefruit USA Inc (GPFT)

[eagleagain2002]

Repair and refurbishment by definition IS manufacturing. Machines are dis-assembled, parts repaired and/or replaced and re-assembled. The process if done correctly requires written procedures, documentation of work completed and a quality assurance system, all recognized aspects of a manufacturing operation.The point is that it may not be directly related to the 510K, the FDA would be foolish not to look at existing manufacturing capability during the approval process just to be certain they are dealing with a legitimate and capable company. Let's not spin something that IS, into something that isn't.