The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Icu Medical Needle, Lopez Needle.
| Device ID | K860781 |
| 510k Number | K860781 |
| Device Name: | ICU MEDICAL NEEDLE, LOPEZ NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ICU MEDICAL, INC. 5200 WARNER AVENUE, STE. 108 Huntington Beach, CA 92649 |
| Contact | George A Lopez |
| Correspondent | George A Lopez ICU MEDICAL, INC. 5200 WARNER AVENUE, STE. 108 Huntington Beach, CA 92649 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-03 |
| Decision Date | 1986-05-06 |