The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic Ileal Reservoir Catheter.
| Device ID | K760860 |
| 510k Number | K760860 |
| Device Name: | SILASTIC ILEAL RESERVOIR CATHETER |
| Classification | Collector, Ostomy |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 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 | 1976-10-18 |
| Decision Date | 1976-11-23 |