Pen, MARK-3 Skin Marking Fountain
FDA 510(k) K781694 · Omega Mark-3 Pen Corp.
510(k) numberK781694
Submission
- Device name
- Pen, MARK-3 Skin Marking Fountain
- Applicant
- Omega Mark-3 Pen Corp.
Mchenry, IL, US - Received
- October 10, 1978
- Decision date
- December 4, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FZZ – Marker, Skin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4660
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042555 | Surgichip Tag Surgical MarkerFZZ · Traditional | Surgichip, Inc. | 11/09/2004SE |
| K915066 | Disposable Skin MarkerFZZ · Traditional | American Medical Mfg., Inc. | 05/14/1992SE |
| K914759 | Bloom Transparent StencilFZZ · Traditional | Freckles Publications, Inc. | 04/21/1992SE |
| K912730 | Rocket Surgical Skin Marking PenFZZ · Traditional | West Texas Lighthouse For the Blind | 11/07/1991SE |
| K905143 | Skin MarkerFZZ · Traditional | Aesculap, Inc. | 02/06/1991SE |
| K904559 | Qualtex Skin MarkerFZZ · Traditional | Qualtex, Inc. | 12/13/1990SE |
| K896792 | Surgical Skin MarkerFZZ · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 12/27/1989SE |
| K864371 | Surgical Skin MarkerFZZ · Traditional | Myocure, Inc. | 11/17/1986SE |
| K863280 | DermamarkerFZZ · Traditional | Dermacare Products, Inc. | 09/09/1986SE |
| K861772 | Laser Skin Marker and Mask White LotionFZZ · Traditional | Pacific Poly Crafts | 05/21/1986SE |
Questions and answers
When was Pen, MARK-3 Skin Marking Fountain cleared by the FDA?
Pen, MARK-3 Skin Marking Fountain (K781694) received a 510(k) decision of Substantially Equivalent on December 4, 1978, 55 days after the submission was received.
What is the product code of K781694?
The FDA product code is FZZ – Marker, Skin, a Class I (low risk) device regulated under 21 CFR 878.4660.