The following data is part of a premarket notification filed by Filtertek, Inc. with the FDA for Pn 62290 0.22 Micron Micro Infus I.v. Exten Set.
| Device ID | K914792 |
| 510k Number | K914792 |
| Device Name: | PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-23 |
| Decision Date | 1992-01-15 |