K830721 is an FDA 510(k) clearance for the WIRE TWISTERS. This device is classified as a Pliers, Surgical (Class I - General Controls, product code HTC).
Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983, 35 days after receiving the submission on March 8, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K830721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1983 |
| Decision Date | April 12, 1983 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HTC — Pliers, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |