The following data is part of a premarket notification filed by Genesis Bps Llc with the FDA for Flu-admin, Models 60150, 60150c, 60151c, 60153c, 60160.
| Device ID | K082027 |
| 510k Number | K082027 |
| Device Name: | FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160 |
| Classification | Set, Administration, Intravascular |
| Applicant | GENESIS BPS LLC 65 COMMERCE WAY Hackensack, NJ 07601 |
| Contact | Carolyn Amditis |
| Correspondent | Carolyn Amditis GENESIS BPS LLC 65 COMMERCE WAY Hackensack, NJ 07601 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-17 |
| Decision Date | 2009-02-13 |
| Summary: | summary |