Application Form - RTS for expedited 510(k) clearances

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Application Form | CON-F-0002

Please provide information about your Company and Medical Device.

Note: Please click Request a Quote button only once. Allow the system to finish processing and redirect you to our confirmation page. Thank you.

SUBMITTER, APPLICANT OR SPONSOR INFORMATION

Salutation: *

First Name: *

Last Name: *

Job Title:

Email Address: *

Office Phone: *

Company Name: *

Street Address: *

City: *

State: *

Postalcode: *

Country: *

DEVICE OR PRODUCT INFORMATION

Device Name: *

Product Code:
(If applicable, please include all Product Codes separated by a Comma) *

C.F.R. Section:
(If applicable, please include all C.F.R. Sections separated by a Comma) *

Common Name: *

Device Class: *

Classification Panel: *

Purpose of Submission: *

Does the Device Software contain Artificial Intelligence / Machine Learning (AI/ML)?: *

Does the submission contain clinical data?: *

Additional Information / Other Comments:

Planned Date of Submission: *

Predicate Device: *

Predicate Device – 510(k) Number: *

How did you hear about us? *

Please solve the CAPTCHA (simple math problem) below:

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Note: Please click Request a Quote button only once. Allow the system to finish processing and redirect you to our confirmation page. Thank you.