The following data is part of a premarket notification filed by Innovative Medical Technologies, Inc. with the FDA for Improve Blood Collection Set And Improsafe Blood Collection Set.
| Device ID | K123987 |
| 510k Number | K123987 |
| Device Name: | IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | INNOVATIVE MEDICAL TECHNOLOGIES, INC. 15059 CEDAR ST. Leawood, KS 66224 |
| Contact | Brad Brown |
| Correspondent | Brad Brown INNOVATIVE MEDICAL TECHNOLOGIES, INC. 15059 CEDAR ST. Leawood, KS 66224 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-08-27 |