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 |