The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Epifuse Catheter Connector, Model: 4909e.
| Device ID | K092657 |
| 510k Number | K092657 |
| Device Name: | EPIFUSE CATHETER CONNECTOR, MODEL: 4909E |
| Classification | Anesthesia Conduction Kit |
| Applicant | SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Cindy Engelhardt |
| Correspondent | Cindy Engelhardt SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-28 |
| Decision Date | 2009-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688069269 | K092657 | 000 |
| 30351688074908 | K092657 | 000 |
| 10351688000187 | K092657 | 000 |
| 10351688020789 | K092657 | 000 |
| 10351688028761 | K092657 | 000 |
| 10351688032256 | K092657 | 000 |
| 10351688036568 | K092657 | 000 |
| 10351688037442 | K092657 | 000 |
| 10351688047571 | K092657 | 000 |
| 10351688069238 | K092657 | 000 |
| 10351688069252 | K092657 | 000 |
| 30351688076087 | K092657 | 000 |