The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Two Piece Ostomy System.
| Device ID | K813269 |
| 510k Number | K813269 |
| Device Name: | TWO PIECE OSTOMY SYSTEM |
| Classification | Collector, Ostomy |
| Applicant | HOLLISTER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-20 |
| Decision Date | 1981-12-03 |