The following data is part of a premarket notification filed by Douglas Medical Products, Inc. with the FDA for Tubetech Iv Administration Set.
| Device ID | K162951 |
| 510k Number | K162951 |
| Device Name: | TUBETECH IV Administration Set |
| Classification | Set, Administration, Intravascular |
| Applicant | Douglas Medical Products, Inc. 345 Dunbar Road Mundelein, IL 60060 |
| Contact | Doug Johnson |
| Correspondent | Doug Johnson Douglas Medical Products, Inc. 345 Dunbar Road Mundelein, IL 60060 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-24 |
| Decision Date | 2017-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816415020154 | K162951 | 000 |
| 10816415020031 | K162951 | 000 |
| 10816415020000 | K162951 | 000 |