The following data is part of a premarket notification filed by Summit Medical Ltd. with the FDA for Summit Medical Ltd Celltrans Postoperative Autotransfusion System, Models Abt4510, Abt4512 & Abt4514.
| Device ID | K022489 |
| 510k Number | K022489 |
| Device Name: | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 |
| Classification | Apparatus, Autotransfusion |
| 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 | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-29 |
| Decision Date | 2002-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 25060238201135 | K022489 | 000 |