The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modified Material Used In Infusion T.
| Device ID | K893909 |
| 510k Number | K893909 |
| Device Name: | MODIFIED MATERIAL USED IN INFUSION T |
| Classification | Set, Administration, Intravascular |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Ron R Duck |
| Correspondent | Ron R Duck QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-30 |
| Decision Date | 1989-08-25 |