The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Lopez Valve With Ng Sump Tube.
| Device ID | K921104 |
| 510k Number | K921104 |
| Device Name: | LOPEZ VALVE WITH NG SUMP TUBE |
| Classification | Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| Applicant | ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Contact | Araceli C Fancher |
| Correspondent | Araceli C Fancher ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Product Code | FEG |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-09 |
| Decision Date | 1992-10-26 |