SURGICAL SKIN MARKER
Device Facts
| Record ID | K896792 |
|---|---|
| Device Name | SURGICAL SKIN MARKER |
| Applicant | Westmark, Sterile Packing Systems, Inc. (Sps) |
| Product Code | FZZ · General, Plastic Surgery |
| Decision Date | Dec 27, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4660 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.