The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Regional Anesthesia Trays.
| Device ID | K851134 | 
| 510k Number | K851134 | 
| Device Name: | REGIONAL ANESTHESIA TRAYS | 
| Classification | Anesthesia Conduction Kit | 
| 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 | CAZ | 
| CFR Regulation Number | 868.5140 [🔎] | 
| Decision | Substantially Equivalent - With Drug (SESD) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1985-03-21 | 
| Decision Date | 1985-07-15 |