The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Subcutaneous Tunneling Needles & Handles.
| Device ID | K854327 |
| 510k Number | K854327 |
| Device Name: | SUBCUTANEOUS TUNNELING NEEDLES & HANDLES |
| Classification | Needle, Catheter |
| 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 | GCB |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-28 |
| Decision Date | 1985-11-13 |