The following data is part of a premarket notification filed by Millennium Medical Distribution, Inc. with the FDA for Millennium Huber Plus Safety Infusion Set.
| Device ID | K993848 |
| 510k Number | K993848 |
| Device Name: | MILLENNIUM HUBER PLUS SAFETY INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MILLENNIUM MEDICAL DISTRIBUTION, INC. 1205 DE LA VINA Santa Barbara, CA 93101 |
| Contact | Christine Emanuel |
| Correspondent | Christine Emanuel MILLENNIUM MEDICAL DISTRIBUTION, INC. 1205 DE LA VINA Santa Barbara, CA 93101 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-12 |
| Decision Date | 2000-01-27 |
| Summary: | summary |