The following data is part of a premarket notification filed by Bmw Medical, Inc. with the FDA for Needle-free Valved Connector And Cap.
| Device ID | K964439 |
| 510k Number | K964439 |
| Device Name: | NEEDLE-FREE VALVED CONNECTOR AND CAP |
| Classification | Set, Administration, Intravascular |
| Applicant | BMW MEDICAL, INC. 3598 WEST 1820 SOUTH Salt Lake City, UT 84104 -4959 |
| Contact | Roger L Richins |
| Correspondent | Roger L Richins BMW MEDICAL, INC. 3598 WEST 1820 SOUTH Salt Lake City, UT 84104 -4959 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-06 |
| Decision Date | 1997-07-16 |
| Summary: | summary |