The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit.
| Device ID | K110053 |
| 510k Number | K110053 |
| Device Name: | CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-07 |
| Decision Date | 2012-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688077569 | K110053 | 000 |
| 50351688077552 | K110053 | 000 |
| 30351688077541 | K110053 | 000 |
| 30351688075653 | K110053 | 000 |
| 30351688068433 | K110053 | 000 |
| 30351688068426 | K110053 | 000 |