The following data is part of a premarket notification filed by Filtertek, Inc. with the FDA for I.v. Extender Set.
| Device ID | K911451 |
| 510k Number | K911451 |
| Device Name: | I.V. EXTENDER SET |
| Classification | Filter, Infusion Line |
| Applicant | FILTERTEK, INC. P.O. BOX 310 PRICE RD. Hebron, IL 60034 |
| Contact | Larry Larkin |
| Correspondent | Larry Larkin FILTERTEK, INC. P.O. BOX 310 PRICE RD. Hebron, IL 60034 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-03 |
| Decision Date | 1991-06-06 |