The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for One Time Vial Access Spike.
| Device ID | K934561 |
| 510k Number | K934561 |
| Device Name: | ONE TIME VIAL ACCESS SPIKE |
| Classification | Syringe, Piston |
| Applicant | ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Contact | Salvadore F Palmares |
| Correspondent | Salvadore F Palmares ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-21 |
| Decision Date | 1994-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840619063716 | K934561 | 000 |