The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Hollister(r) Bedside Drainage Collection Syst 9878.
| Device ID | K926570 |
| 510k Number | K926570 |
| Device Name: | HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878 |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Joseph S Tokarz |
| Correspondent | Joseph S Tokarz 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 | 1992-12-31 |
| Decision Date | 1993-05-21 |