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 |