K821289 is an FDA 510(k) clearance for the MAYO-HEGAR NEEDLE HOLDER. This device is classified as a Guide, Needle, Surgical (Class I - General Controls, product code GDF).
Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1982, 30 days after receiving the submission on May 4, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K821289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1982 |
| Decision Date | June 03, 1982 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDF — Guide, Needle, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |