The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Spring Guide Catheter Anesthesia Conduction Cath.
Device ID | K854601 |
510k Number | K854601 |
Device Name: | SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH |
Classification | Catheter, Conduction, Anesthetic |
Applicant | CONCORD LABORATORIES, INC. KIT ST. Keene, NH 03431 |
Contact | Robert Wheeler |
Correspondent | Robert Wheeler CONCORD LABORATORIES, INC. KIT ST. 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 | 1985-11-18 |
Decision Date | 1986-01-10 |