The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Lock-it Plus Regional Anesthesia Catheter Securement Device, Model 100/399/216.
| Device ID | K051524 |
| 510k Number | K051524 |
| Device Name: | LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216 |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | SMITHS MEDICAL ASD, INC. 10 BOWMAN DRIVE Keene, NH 03431 |
| Contact | Cynthia Engelhardt |
| Correspondent | Cynthia Engelhardt SMITHS MEDICAL ASD, INC. 10 BOWMAN DRIVE Keene, NH 03431 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-08 |
| Decision Date | 2005-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688068149 | K051524 | 000 |
| 10351688068132 | K051524 | 000 |