Total Product Life Cycle 510k report
What is inside the report?
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Device Details
![](https://medicaldevice510k.com/wp-content/themes/divi-child/images/mark-icon.png)
Product Details
![](https://medicaldevice510k.com/wp-content/themes/divi-child/images/mark-icon.png)
Device Regulat
on Details
![](https://medicaldevice510k.com/wp-content/themes/divi-child/images/mark-icon.png)
All Manufactures
and Submission
![](https://medicaldevice510k.com/wp-content/themes/divi-child/images/mark-icon.png)
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