The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerloc Clear Safety Infusion Set.
| Device ID | K082306 |
| 510k Number | K082306 |
| Device Name: | POWERLOC CLEAR SAFETY INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Henry Boland |
| Correspondent | Henry Boland C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-13 |
| Decision Date | 2008-08-28 |
| Summary: | summary |