K920816 is an FDA 510(k) clearance for the PERCUGUIDE LESION MARKING, a Guide, Needle, Surgical (Class I — General Controls, product code GDF), submitted by E-Z-Em, Inc. (Glens Falls, US). The FDA issued a Cleared decision on April 21, 1992, 75 days after receiving the submission on February 6, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K920816 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 06, 1992 |
| Decision Date | April 21, 1992 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDF — Guide, Needle, Surgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |