The following data is part of a premarket notification filed by Filtertek, Inc. with the FDA for Nfc Needlefree Y-site, Model 69970.
| Device ID | K981547 |
| 510k Number | K981547 |
| Device Name: | NFC NEEDLEFREE Y-SITE, MODEL 69970 |
| Classification | Set, Administration, Intravascular |
| Applicant | FILTERTEK, INC. 11411 PRICE RD. Hebron, IL 60034 |
| Contact | Larry Larkin |
| Correspondent | Larry Larkin FILTERTEK, INC. 11411 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 | 1998-04-30 |
| Decision Date | 1998-06-18 |
| Summary: | summary |