FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GLOMARK
K Number: K830703
·
Decision Apr 28, 1983
Classifications
1
FEI Numbers
183
Registration Numbers
184
Same Product Code
22
Applicant Total
7
Review Days
52
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Basic Information
- Device Name
- GLOMARK
- K Number
- K830703
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4660
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Alphamedix, Inc.
- Date Received
- March 7, 1983
- Decision Date
- April 28, 1983
- 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 Alphamedix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852706 | VERSABLADE | Nov 4, 1985 | Substantially Equivalent for Some Indications |
| K852633 | VERSABLADE | Nov 4, 1985 | Substantially Equivalent for Some Indications |
| K851272 | VERSAPHAGE | Jul 5, 1985 | Substantially Equivalent |
| K830812 | ALPHAMEDIX I/A HAND-PIECE, 500-001 | Jun 8, 1983 | Substantially Equivalent |
| K820363 | DISPOSABLE SURGICAL GARMENTS | Mar 8, 1982 | Substantially Equivalent |
| K820008 | VERSATOME I | Feb 22, 1982 | Substantially Equivalent |