K905143 is an FDA 510(k) clearance for the SKIN MARKER. This device is classified as a Marker, Skin (Class I - General Controls, product code FZZ).
Submitted by Aesculap, Inc. (Burlingame, US). The FDA issued a Cleared decision on February 6, 1991, 83 days after receiving the submission on November 15, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4660.
| 510(k) Number | K905143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1990 |
| Decision Date | February 06, 1991 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZZ — Marker, Skin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4660 |