The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Self Adhesive Urinary External Cath. W/remove. Tip.
| Device ID | K881678 |
| 510k Number | K881678 |
| Device Name: | SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Jerome A Saxon |
| Correspondent | Jerome A Saxon HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-19 |
| Decision Date | 1988-08-11 |