The following data is part of a premarket notification filed by Hennig Enterprises Europe S.r.l. with the FDA for Go Medical Patient Controlled Analgesia Devices.
| Device ID | K020421 |
| 510k Number | K020421 |
| Device Name: | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES |
| Classification | Pump, Infusion, Pca |
| Applicant | HENNIG ENTERPRISES EUROPE S.R.L. 25 SHANN ST., FLOREAT Perth, AU 6014 |
| Contact | George O'neil |
| Correspondent | George O'neil HENNIG ENTERPRISES EUROPE S.R.L. 25 SHANN ST., FLOREAT Perth, AU 6014 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-07 |
| Decision Date | 2003-04-29 |