Intertek Medical - FDA 510(k) Consulting Request Form

Your name

Company

Email

Address

City

Postal code

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Device Information

Please refer to FDA Product Classification Database at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

Device Common Name:

Device Classification Code:

Regulation (21 CFR) Number:

Have you identified predicate device and/or comparable device that have been previously 510(k) cleared by FDA?

If yes, identify the 510(k) Number:

Reason for Submission?

Has Device ever been submitted to FDA?

If Yes – briefly describe about the outcome of the previous submission, any subsequent changes to the device for new submission:

Does the Device incorporate Software?

Is the Device provided sterile?