K904869 is an FDA 510(k) clearance for the ELLIPSE PUNCH. This device is classified as a Punch, Surgical (Class I - General Controls, product code LRY).
Submitted by Kramer Const (Palo Alto, US). The FDA issued a Cleared decision on March 6, 1991, 128 days after receiving the submission on October 29, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K904869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 1990 |
| Decision Date | March 06, 1991 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | LRY — Punch, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |