The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Regional Anesthesia Trays.
| Device ID | K965017 |
| 510k Number | K965017 |
| Device Name: | REGIONAL ANESTHESIA TRAYS |
| Classification | Anesthesia Conduction Kit |
| Applicant | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-16 |
| Decision Date | 1997-03-14 |
| Summary: | summary |