The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Female Ic (not Finalized).
| Device ID | K213575 |
| 510k Number | K213575 |
| Device Name: | Female IC (Not Finalized) |
| Classification | Catheter, Straight |
| Applicant | Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 |
| Contact | Michelle Schiltz-Taing |
| Correspondent | Michelle Schiltz-Taing Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-10 |
| Decision Date | 2022-09-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00610075072712 | K213575 | 000 |
| 00610075072705 | K213575 | 000 |
| 00610075072699 | K213575 | 000 |
| 00610075072644 | K213575 | 000 |