Securline Surgical Skin Marker 1000
FDA 510(k) K840820 · Precision Dynamics Corp.
510(k) numberK840820
Submission
- Device name
- Securline Surgical Skin Marker 1000
- Applicant
- Precision Dynamics Corp.
Mchenry, IL, US - Received
- February 24, 1984
- Decision date
- April 25, 1984
- 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 |
More from Pacific Poly Crafts
| 510(k) | Device | Decision |
|---|---|---|
| K161920 | Comfort CoverIZH · Traditional | 07/15/2016SE |
| K020718 | Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-SterileHFW · Traditional | 06/03/2002SE |
| K994353 | Secureline Disposable Fetal Monitoring Straps #3860 and #3565HFM · Traditional | 03/22/2000SE |
| K994263 | Securline Umbilical Cord Clamp Clipper #3540HFW · Traditional | 01/24/2000SE |
| K990737 | 'Ecurline Umbilical Cord Clamp #3500HFW · Traditional | 04/06/1999SE |
| K884357 | Precision Bioport Collection & Transport SystemKOT · Traditional | 11/01/1988SE |
| K882580 | Mechanical Change in In-Vitro Micro DeviceJTW · Traditional | 07/08/1988SE |
| K874665 | Securline Fine Needle Aspiration Biopsy TrayLRP · Traditional | 01/20/1988SESD |
| K873369 | Securline Franseene NeedleKNW · Traditional | 10/20/1987SE |
| K872507 | Precision Culture C.A.T.S. Collect/Trans HSV I/IiJSM · Traditional | 07/09/1987SE |
Questions and answers
When was Securline Surgical Skin Marker 1000 cleared by the FDA?
Securline Surgical Skin Marker 1000 (K840820) received a 510(k) decision of Substantially Equivalent on April 25, 1984, 61 days after the submission was received.
What is the product code of K840820?
The FDA product code is FZZ – Marker, Skin, a Class I (low risk) device regulated under 21 CFR 878.4660.