Total Product Life Cycle 510k report
What is inside the report?

Device Details

Product Details

Device Regulat
on Details

All Manufactures
and Submission

FDA decision
letter (510k, PMA)
Check your device class, regulation and
510k requirement
Don’t know the product code
510k Phases
- 1
-
2
Check your device is required 510k submission or 510k exempt
-
3
Get the 510k Total Product Life Cycle Report within 48 hours
(Review FDA decision letter and substantial device)
-
4
Prepare 510k submission
-
5
Submit 510k to FDA
Difficulty to decide your product code
Please contact us
medicaldevice510k@gmail.com