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Application Form
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Please fill out the Application Form | CON-F-0002 online or download the Application Form | CON-F-0002 and send us the completed Form. Thank you.

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: *

Fax:

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: *

Additional Information / Other Comments:
Does the Software contain Artificial Intelligence / Machine Learning (AI/ML)? *

Planned Date of Submission: *

Predicate Device: *

Predicate Device - 510(k) Number: *

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

REGULATORY TECHNOLOGY SERVICES
ACCREDITED BY THE FDA'S ACCREDITED PERSONS PROGRAM
PHONE: 763.682.4139, FAX:763.682.4420, EMAIL: PRITHUL.BOM@RTS3PRO.COM
1000 WESTGATE DRIVE, #510K, SAINT PAUL, MN 55114, UNITED STATES