The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Dri-vent Arterial Blood Sampling Kit.
| Device ID | K883840 |
| 510k Number | K883840 |
| Device Name: | DRI-VENT ARTERIAL BLOOD SAMPLING KIT |
| Classification | Pad, Alcohol, Device Disinfectant |
| 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 | LKB |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-12 |
| Decision Date | 1989-05-16 |