Skin Markers
FDA 510(k) K821063 · Devon Industries, Inc.
510(k) numberK821063
Submission
- Device name
- Skin Markers
- Applicant
- Devon Industries, Inc.
Mchenry, IL, US - Received
- March 7, 1982
- Decision date
- June 25, 1982
- 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 |
|---|---|---|
| K961993 | Birthday Kit (Obstetrical Delivery Kit)MLS · Traditional | 07/03/1996SE |
| K954015 | Abg Point Lok Needle Protection DeviceCBT · Traditional | 11/20/1995SE |
| K946289 | Devons Point Lok Needle Protection DeviceFMI · Traditional | 07/10/1995SE |
| K945197 | The Sharps Collection and Disposal SystemMMK · Traditional | 12/02/1994SE |
| K944114 | Phlebotomy Unit Sharps a GatorFMI · Traditional | 12/02/1994SE |
| K943892 | Point of Use Sharps a GatorFMI · Traditional | 12/02/1994SE |
| K945485 | Abg Needle ProtectionCBT · Traditional | 11/29/1994SE |
| K932998 | Easy-OnGES · Traditional | 08/18/1993SE |
| K912824 | Devon Sponge Counter BagsLWH · Traditional | 08/26/1991SE |
| K894170 | Devon Disposable Head Positioner CoverKME · Traditional | 09/07/1989SE |
Questions and answers
When was Skin Markers cleared by the FDA?
Skin Markers (K821063) received a 510(k) decision of Substantially Equivalent on June 25, 1982, 110 days after the submission was received.
What is the product code of K821063?
The FDA product code is FZZ – Marker, Skin, a Class I (low risk) device regulated under 21 CFR 878.4660.