FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DERMAMARKER
K Number: K863280
·
Decision Sep 9, 1986
Classifications
1
FEI Numbers
183
Registration Numbers
184
Same Product Code
22
Applicant Total
8
Review Days
15
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Basic Information
- Device Name
- DERMAMARKER
- K Number
- K863280
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4660
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Dermacare Products, Inc.
- Date Received
- August 25, 1986
- Decision Date
- September 9, 1986
- Product Code
- FZZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FZZ | Marker, Skin | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZZ), ordered by most recent decision date.
SURGICHIP TAG SURGICAL MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BLOOM TRANSPARENT STENCIL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ROCKET SURGICAL SKIN MARKING PEN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
QUALTEX SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Dermacare Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882494 | ELAN-E DISPOSALBE DRAPE | Jul 8, 1988 | Substantially Equivalent |
| K882421 | INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE | Jun 30, 1988 | Substantially Equivalent |
| K871910 | SURGITEK DISPOSABLE BIPOLAR CORD | Jun 1, 1987 | Substantially Equivalent |
| K863279 | SURGI-TEK TUBE POSITIONER | Sep 9, 1986 | Substantially Equivalent |
| K863278 | SURGI-WIPES | Sep 2, 1986 | Substantially Equivalent |
| K862367 | PRO-CLEAN | Jul 8, 1986 | Substantially Equivalent |
| K853374 | CORRECT-A-COUNT | Sep 5, 1985 | Substantially Equivalent |