{docinfo.knumber} - {docinfo.device_name}

[FDA⇒]

{docinfo.applicant}
{docinfo.street1}
{docinfo.street2}
{docinfo.city}, {docinfo.state} {docinfo.postal_code}

Product Code: {docinfo.product_code}
Date Received: {date_received}
Decision Date: {decision_date}

510(k) Full Submission

The FDA has made available a redacted submission for this 510(k). Redacted submissions do not contain testing data.

[FDA Full Submission (WARNING: Large File!)⇒]

1}> Submissions like this take an average of { Math.round(docinfo.average) } days to clear the FDA, but that's only a small part of the journey.

Contact in2being to find out how we can help develop your { committee } device and keep you on the right path.

ID	Approval Date	Description	Applicant
{knumber}	{decision_date.substring(0,10)}	{device_name}	{applicant}