SKIN MARKERS
FDA 510(k) clearance K821063 · decided 1982-06-25
Clearance details
- K-number
- K821063
- Device name
- SKIN MARKERS
- Applicant
- Devon Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-03-07
- Decision date
- 1982-06-25
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- FZZ
- Device class
- 1
- Regulation number
- 878.4660
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SURGICHIP TAG SURGICAL MARKER (K042555) | Surgichip, Inc. | 2004-11-09 |
| DISPOSABLE SKIN MARKER (K915066) | American Medical Mfg., Inc. | 1992-05-14 |
| BLOOM TRANSPARENT STENCIL (K914759) | Freckles Publications, Inc. | 1992-04-21 |
| ROCKET SURGICAL SKIN MARKING PEN (K912730) | West Texas Lighthouse For the Blind | 1991-11-07 |
| SKIN MARKER (K905143) | Aesculap, Inc. | 1991-02-06 |
| QUALTEX SKIN MARKER (K904559) | Qualtex, Inc. | 1990-12-13 |
| SURGICAL SKIN MARKER (K896792) | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 |
| SURGICAL SKIN MARKER (K864371) | Myocure, Inc. | 1986-11-17 |
| DERMAMARKER (K863280) | Dermacare Products, Inc. | 1986-09-09 |
| LASER SKIN MARKER AND MASK WHITE LOTION (K861772) | Pacific Poly Crafts | 1986-05-21 |
| SECURLINE SURGICAL SKIN MARKER 1000 (K844865) | Precision Dynamics Corp. | 1985-01-14 |
| DISPOSABLE SKIN MARKING PEN (K843116) | E.M. Adams | 1984-08-17 |
Recalls involving this device
No recalls on record reference this clearance.