The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Hollister Drainage Pouch.
| Device ID | K801504 |
| 510k Number | K801504 |
| Device Name: | HOLLISTER DRAINAGE POUCH |
| Classification | Bag, Drainage, With Adhesive, Ostomy |
| Applicant | HOLLISTER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FON |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-27 |
| Decision Date | 1980-08-12 |