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 |