The following data is part of a premarket notification filed by Graseby Medical Ltd. with the FDA for Patient Controlled Syringe Pump Type 3300.
| Device ID | K915270 |
| 510k Number | K915270 |
| Device Name: | PATIENT CONTROLLED SYRINGE PUMP TYPE 3300 |
| Classification | Pump, Infusion, Pca |
| Applicant | GRASEBY MEDICAL LTD. COLONIAL WAY Watford, Herts., GB Wd24 4lg |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-25 |
| Decision Date | 1992-08-24 |