The following data is part of a premarket notification filed by Marlen Mfg. & Development Co. with the FDA for Marlen Ultra Ileostomy Pouch-5000.
| Device ID | K880327 |
| 510k Number | K880327 |
| Device Name: | MARLEN ULTRA ILEOSTOMY POUCH-5000 |
| Classification | Pouch, Colostomy |
| Applicant | MARLEN MFG. & DEVELOPMENT CO. 5150 RICHMOND RD. Bedford, OH 44146 |
| Contact | Fenton |
| Correspondent | Fenton MARLEN MFG. & DEVELOPMENT CO. 5150 RICHMOND RD. Bedford, OH 44146 |
| Product Code | EZQ |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-02-19 |