The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Tracheobronchial Suction Catheter, Cat. No. 6110.
| Device ID | K864535 |
| 510k Number | K864535 |
| Device Name: | TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 |
| 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 | 1986-11-17 |
| Decision Date | 1987-01-06 |