The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Meconium Suction Catheter.
| Device ID | K871825 |
| 510k Number | K871825 |
| Device Name: | MECONIUM SUCTION CATHETER |
| Classification | Catheters, Suction, Tracheobronchial |
| 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 | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-11 |
| Decision Date | 1987-06-29 |