K854327 is an FDA 510(k) clearance for the SUBCUTANEOUS TUNNELING NEEDLES & HANDLES. This device is classified as a Needle, Catheter (Class I - General Controls, product code GCB).
Submitted by Concord Laboratories, Inc. (Keene, US). The FDA issued a Cleared decision on November 13, 1985, 16 days after receiving the submission on October 28, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K854327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1985 |
| Decision Date | November 13, 1985 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GCB — Needle, Catheter |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |