Name *

First Name

Last Name

DEVICE CLASS

Class I

Class II

Purpose of Submission *

New Submission – Please describe the product below

Resubmission – Please indicate the reason below

Other Purpose – Please indicate the purpose below

I understand by submitting this request I accept the privacy policy of GQRS *

GQRS is committed to protecting your privacy. We will not share your information with others without your written consent. Under the Data Protection Act, we have a legal duty to protect any private (non-public) information you share with us. Electronic and hard-copy records will always be secured, and there will be restricted access to all records to prevent unauthorized use or tampering. You are required to share any correspondence you might have had with the FDA about this device. After we complete our review, we will provide our decision along with the 510(k) summary, review materials, and all supporting documents to the FDA CDRH. All review records will be kept for three (3) years following the submission of review materials to the FDA. After the retention period ends, records will either be securely discarded or, if requested, transferred to the FDA.

I ACCEPT