FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SILVERLON CONTACT WOUND DRESSING
K Number: K981299
·
Decision Sep 25, 1998
Classifications
1
FEI Numbers
402
Registration Numbers
403
Same Product Code
861
Applicant Total
8
Review Days
169
Basic Information
- Device Name
- SILVERLON CONTACT WOUND DRESSING
- K Number
- K981299
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ARGENTUM INTERNATIONAL LLC.
- Date Received
- April 9, 1998
- Decision Date
- September 25, 1998
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by ARGENTUM INTERNATIONAL LLC.
| K Number | Device Name | ||
|---|---|---|---|
| K984207 | SILVERLON DIRECT PRESSURE WOUND DRESSING | Mar 19, 2007 | Substantially Equivalent |
| K984204 | SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP | Mar 19, 2007 | Substantially Equivalent |
| K984205 | SILVERLON ADHESIVE STRIP | Mar 19, 2007 | Substantially Equivalent |
| K023612 | SILVERLON CONTACT WOUND DRESSING | Jan 24, 2003 | Substantially Equivalent |
| K023609 | SILVERLON ADHESIVE STRIP | Jan 17, 2003 | Substantially Equivalent |
| K984210 | SILVERLON WOUND PACKING STRIPS | Sep 24, 1999 | Substantially Equivalent |
| K984208 | SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD | Feb 22, 1999 | Substantially Equivalent |