Premarket Notification Submission 510(k), Subpart E

ICR 202306-0910-007

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0120 can be found here:

Forms and Documents

Document Name	Status
Form FDA 3881 Premarket Notification Submissions Form	Modified
0120 Premarket Notification SSA 2023 REV.docx Supporting Statement A	2023-06-29
0889 and 0120 eSTAR Change Request SEPT 2021 Final.docx Justification for No Material/Nonsubstantive Change	2021-09-10

IC Document Collections

IC ID	Document Title	Status
5734	Premarket Notification Submissions Form	Modified

ICR Details