The following data is part of a premarket notification filed by Qualtex, Inc. with the FDA for Qualtex Skin Marker.
| Device ID | K904559 |
| 510k Number | K904559 |
| Device Name: | QUALTEX SKIN MARKER |
| Classification | Marker, Skin |
| Applicant | QUALTEX, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning QUALTEX, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | FZZ |
| CFR Regulation Number | 878.4660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-05 |
| Decision Date | 1990-12-13 |