The following data is part of a premarket notification filed by Summit Medical Ltd. with the FDA for Summit Medical Ltd Transfusion Filter, Model Lf400 & Summit Medical Ltd Transfusion Filter With Administration Set.
| Device ID | K022477 |
| 510k Number | K022477 |
| Device Name: | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET |
| Classification | Microfilter, Blood Transfusion |
| Applicant | SUMMIT MEDICAL LTD. BUSINESS & TECHNOLOGY CENTRE BESSEMER DRIVE Stevenage Hertfordshire, GB Sgi 2dx |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong SUMMIT MEDICAL LTD. BUSINESS & TECHNOLOGY CENTRE BESSEMER DRIVE Stevenage Hertfordshire, GB Sgi 2dx |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-29 |
| Decision Date | 2002-10-25 |
| Summary: | summary |