The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Hydroflow Suction Irrigation System.
| Device ID | K833189 |
| 510k Number | K833189 |
| Device Name: | HYDROFLOW SUCTION IRRIGATION SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PORTEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-19 |
| Decision Date | 1983-11-28 |