The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Lopez Lock.
| Device ID | K840273 |
| 510k Number | K840273 |
| Device Name: | LOPEZ LOCK |
| Classification | Set, Administration, Intravascular |
| Applicant | ICU MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-23 |
| Decision Date | 1984-03-06 |