Regulatory Technology Services

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Application Form
(54K)
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.

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:

Planned Date of Submission:

Predicate Device: *

Predicate Device - 510(k) Number: *

Predicate Device Clearance Date:

Regulatory Technology Services
We are accredited by the FDA's Accredited Person Program
Phone: 763.682.4139 Fax: 763.682.4420 E-mail: contact@rts3pro.com