The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Rapid Add Site Double Lumen I.v.extension Set.
| Device ID | K915109 |
| 510k Number | K915109 |
| Device Name: | RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Contact | E.martin Chamberlain |
| Correspondent | E.martin Chamberlain BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-13 |
| Decision Date | 1992-05-08 |