The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Hr(tm) Needle And Syringe.
| Device ID | K874372 |
| 510k Number | K874372 |
| Device Name: | HR(TM) NEEDLE AND SYRINGE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ICU MEDICAL, INC. 23436 MADERO ST. Mission Viejo, CA 92691 |
| Contact | Fred Mclendon |
| Correspondent | Fred Mclendon ICU MEDICAL, INC. 23436 MADERO ST. Mission Viejo, CA 92691 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-26 |
| Decision Date | 1987-11-06 |