The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Modification To Ez Huber Safety Infusion Set.
| Device ID | K071846 |
| 510k Number | K071846 |
| Device Name: | MODIFICATION TO EZ HUBER SAFETY INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE SUITE A Oceanside, CA 92056 |
| Contact | Salvadore Palomares |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-07-05 |
| Decision Date | 2007-08-30 |
| Summary: | summary |