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psm34 replied to the topic Product PMOA Classification with FDA Branches in the forum Introduction to Project Management 7 years, 5 months ago
This one might be a layup but a pretty common one would be a first aid kit. They have aspririn and antibiotic cream that would go through CDER which are probably class 2 with 510k. The bandages and gauze would go through the CDHR and be a class 1 device.