The following data is part of a premarket notification filed by Biolog, Inc. with the FDA for Dispos. Drainabel Pouch For Ileostomy/colostomy.
| Device ID | K850751 |
| 510k Number | K850751 |
| Device Name: | DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY |
| Classification | Collector, Ostomy |
| Applicant | BIOLOG, INC. 3447 INVESTMENT BLVD. STE 3 Hayward, CA 94545 |
| Contact | Don Barnby |
| Correspondent | Don Barnby BIOLOG, INC. 3447 INVESTMENT BLVD. STE 3 Hayward, CA 94545 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-25 |
| Decision Date | 1985-05-23 |