Information Collection Request
Premarket Notification Submission 510(k), Subpart E
ICR 202306-0910-007 · OMB 0910-0120 · Received in OIRA
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0120 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form FDA 3881 Premarket Notification Submissions |
Form | Modified | Repair queued |
 0120 Premarket Notification SSA 2023 REV.docx |
Supporting Statement A | Uploaded 2023-06-29 | Repair queued |
| 0889 and 0120 eSTAR Change Request SEPT 2021 Final.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2021-09-10 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 5734 |  Premarket Notification Submissions |
Form | Modified |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0120 |
| Type of Information Collection | Revision of a currently approved collection |
| Previous ICR Reference No | 202109-0910-003 |
| Agency Tracking No | CDRH |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |