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 |