The following data is part of a premarket notification filed by Abbott Laboratories Inc with the FDA for Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain Management.
| Device ID | K023062 |
| 510k Number | K023062 |
| Device Name: | GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT |
| Classification | Pump, Infusion |
| Applicant | ABBOTT LABORATORIES INC 200 ABBOTT PARK RD. DEPT 0389 BLDG J-45 Abbott Park, IL 60064 -6133 |
| Contact | Frank Pokrop |
| Correspondent | Frank Pokrop ABBOTT LABORATORIES INC 200 ABBOTT PARK RD. DEPT 0389 BLDG J-45 Abbott Park, IL 60064 -6133 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-16 |
| Decision Date | 2002-09-30 |
| Summary: | summary |