The following data is part of a premarket notification filed by Medikmark, Inc. with the FDA for Iv Start Kit.
| Device ID | K953474 |
| 510k Number | K953474 |
| Device Name: | IV START KIT |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDIKMARK, INC. 900 ASBURY DR. Buffalo Grove, IL 60089 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-24 |
| Decision Date | 1995-10-02 |