The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Intermittent Catheter (not Finalized).
| Device ID | K211436 |
| 510k Number | K211436 |
| Device Name: | Intermittent Catheter (Not Finalized) |
| Classification | Catheter, Urethral |
| 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 | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-10 |
| Decision Date | 2022-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610075072443 | K211436 | 000 |
| 10610075072436 | K211436 | 000 |
| 10610075072429 | K211436 | 000 |
| 10610075072412 | K211436 | 000 |
| 10610075072405 | K211436 | 000 |
| 10610075072399 | K211436 | 000 |
| 10610075072382 | K211436 | 000 |
| 10610075072368 | K211436 | 000 |
| 10610075072351 | K211436 | 000 |