Dermamarker
FDA 510(k) K863280 · Dermacare Products, Inc.
510(k) numberK863280
Submission
- Device name
- Dermamarker
- Applicant
- Dermacare Products, Inc.
Louisville, KT, US - Received
- August 25, 1986
- Decision date
- September 9, 1986
- 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 |
| K861772 | Laser Skin Marker and Mask White LotionFZZ · Traditional | Pacific Poly Crafts | 05/21/1986SE |
| K844865 | Securline Surgical Skin Marker 1000FZZ · Traditional | Precision Dynamics Corp. | 01/14/1985SE |
More from Precision Dynamics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K882494 | Elan-E Disposalbe DrapeKKX · Traditional | 07/08/1988SE |
| K882421 | Infant Electrosurgical Dispersive ElectrodeJOS · Traditional | 06/30/1988SE |
| K871910 | Surgitek Disposable Bipolar CordGEI · Traditional | 06/01/1987SE |
| K863279 | Surgi-Tek Tube Positioner · Traditional | 09/09/1986SE |
| K863278 | Surgi-Wipes · Traditional | 09/02/1986SE |
| K862367 | Pro-Clean · Traditional | 07/08/1986SE |
| K853374 | Correct-A-Count · Traditional | 09/05/1985SE |
Questions and answers
When was Dermamarker cleared by the FDA?
Dermamarker (K863280) received a 510(k) decision of Substantially Equivalent on September 9, 1986, 15 days after the submission was received.
What is the product code of K863280?
The FDA product code is FZZ – Marker, Skin, a Class I (low risk) device regulated under 21 CFR 878.4660.