FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL SKIN MARKER
K Number: K896792
·
Decision Dec 27, 1989
Classifications
1
FEI Numbers
183
Registration Numbers
184
Same Product Code
22
Applicant Total
28
Review Days
26
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Basic Information
- Device Name
- SURGICAL SKIN MARKER
- K Number
- K896792
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4660
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Westmark, Sterile Packing Systems, Inc. (Sps)
- Date Received
- December 1, 1989
- Decision Date
- December 27, 1989
- 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 Westmark, Sterile Packing Systems, Inc. (Sps)
| K Number | Device Name | ||
|---|---|---|---|
| K896800 | IRRIGATION TRAY | May 24, 1990 | Unknown |
| K896799 | PARACERVICAL/PUDENDAL TRAYS | Apr 23, 1990 | Substantially Equivalent |
| K896559 | INFANT FEEDING TUBE | Mar 13, 1990 | Substantially Equivalent |
| K896794 | SPECIMEN CONTAINER | Mar 1, 1990 | Substantially Equivalent |
| K896806 | CATHETER PLUG/PROTECTOR | Feb 26, 1990 | Substantially Equivalent |
| K896798 | TRACHEOSTOMY TRAY | Feb 22, 1990 | Substantially Equivalent |
| K896797 | SUCTION CATHETER KIT | Feb 16, 1990 | Substantially Equivalent |
| K896215 | MERCY HIP/KNEE PACK | Feb 13, 1990 | Substantially Equivalent |
| K896804 | MANIFOLD | Feb 8, 1990 | Substantially Equivalent |
| K896556 | UNIVERSAL POOLE SUCTION TUBE | Feb 6, 1990 | Substantially Equivalent |