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 |