The following data is part of a premarket notification filed by Summit Medical Ltd. with the FDA for Summit Medical Ltd Celltrans Postoperative Autotransfusion Set, Models Ab400-10, Ab400-12, Ab400-14.
| Device ID | K024097 |
| 510k Number | K024097 |
| Device Name: | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 |
| 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 | 2002-12-12 |
| Decision Date | 2003-02-14 |
| Summary: | summary |